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2BUQV-HS-OT10MVideo otoscope

ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD.
Video otoscope - FCC ID 2BUQV-HS-OT10M - ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD.
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Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
Mar 24, 2026
Application Purpose
Original Equipment
Equipment Note
Video otoscope
Frequency Range
2412.00000000 - 2462.00000000
Company
ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD.
Country
China

Documents & Files

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Users Manual

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Attestation Statements

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Cover Letter(s)

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External Photos

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ID Label/Location Info

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Internal Photos

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RF Exposure Info

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Test Report

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Test Setup Photos

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

Wi-Fi Otoscope Video Otoscope Please read this manual before use the device to ensure proper action during use of these medical grade instruments. Only trained practitioners of these devices can use this product. After reading, please keep this manual in a safe place in case you need to consult it. With stable performance and plug and play, this product is the best instrument for diagnosis, teaching and remote consultation in ENT. Symbols: Manufacturer Electric shock protection Class II equipment Authorized Representative in Europe Symbol for the marking of electrical and electronics devices according to 2002/96/EC. The device, accessories and the packaging have to be disposed of waste correctly at the end of the usage, please follow Local Ordinances or Regulations for disposal. Type B Applied Part Attention, consult relative documents SAFETY INFORMATION Basic safety measures should always be followed including the warnings and cautions listed in this instruction manual. Warnings & Cautions: ● Please don’t use the device exposed to flammable gas. ● Protect all device parts from water, moisture, impact, dropping, direct sunlight, heat and fire, freezing, wind, dust, fumes, oils, perfumes, leaking batteries/corrosive substances and animals. ● Please don’t touch the camera lens directly, or touch it with a sharp object. ● This device has no spare light bulb to replace. ● Do not use corrosive or polishing solution to clean the instrument. ● Please do not share with humans and animals, and place the instrument out of reach of children and animals. ● Please don’t disassemble or repair the device or components. The warranty will be invalid if this has been attempted. Routine maintenance per this manual is accepted. ● Store the instruments in box in a dry room at normal room temperature. GENERAL FEATURES ● Lightweight and compact, easy-to-operate form factor. ● Professional optical lens, clear image with little distortion. ● Professional upper computer operation software. ● Key switch can take pictures and adjust the brightness in as fig.1. ● 2000mAh battery for extended battery life. ● High display LED cold white light source. ● Ear speculum screw-in type for easy replacement. ● Automatic white balance. ● Type-c port compatibility. ● Support Android, IOS applications. HOW TO USE THIS DEVICE fig.2 fig.3 fig.4 fig.5 ● Scan the QR code with your phone or tablet to download and install the app as fig.2 or search for "Video Otoscope" in App Store to download and install. ● Take out the instrument from the storage box, and press the power button for 3sec to turn on the power as fig.3. Then the white light illuminates, it signals the waiting for the online state. ● Go to the Wi-Fi settings on your phone or tablet and turn on Wi-Fi (WLAN) interface and tap "HS-E02-xxxxxx" connect device "HS-E02-xxxxxx" connected, at this time the indicator on the instrument indicates that the green light is long on Exit the WI-FI setting or return to the "Video Otoscope" APP interface to display the image in front of the instrument lens. ● Click take photo, long press to hold start recording video, release your finger to end the recording video. Or lightly press the instrument's power button to take photo, in as fig.3. ● Click "file" to photos and videos preview, when previewing an image, clicking the "Share" in the top-right corner allows you to send the image to a specified location. ● Press the instrument button repeatedly to adjust the lens illumination brightness. ● Insert the appropriate ear speculum in the upper front end of the otoscope as fig.4 and tighten them clockwise. DEVICE OVERVIEW Video Otoscope are used for the direct examination of the auditory canal and tympanic membrane. Any use other than that described here is not in accordance of the intended use of the product, we are not liable for any resulting damages. Only a trained practitioner in these skills is allowed to use these devices. PACKAGE LIST Common accessories for the otoscope such as ear specula are available from us. ● The body of otoscope 1pc ● USB cable 1pc ● Ear Speculum tips 4mm,5mm 6pcs in all ● Instruction manual 1pc 4050165 Rev.B02, Jan.2026 ● Place the tip of the ear cover of the otoscope gently into the external ear canal along the axis of the external ear canal of the subject. The examiner observes the ear canal and eardrum through a mobile phone or flat screen. ● Press and hold the power button for 3sec to turn off the power after use. ● The instrument charging as fig.5, the instrument is charged with a 5v adapter or computer USB port that meets the safety requirements. The blue indicator lights up when charging, and the blue light is extinguished when full. ● When the battery is low, it takes approximately 4 hours to fully charge. ATTENTION FOR USES ● Instruments in operation will automatically switch off after one minute if no action is taken. ● When the instrument is switched off or no image is displayed on the app interface, you must re-enable Wi-Fi on your mobile phone or tablet and connect to the "HS-E02-xxxxxx" device. ● The otoscope should only be used to examine an ear when a speculum is fitted. ● When using, access the speculum end softly from the external ear canal. ● When using the product temperature will rise slightly (maximum 40°C), no impact on the human body, please rest assured to use. ● When cleaning the lens, it is recommended to use alcohol swab carefully and gently wipe. ● Observe the surroundings before and during use. Do not use the product in an environment with people running or obvious seismic sensation. ● It is recommended for children over 1 year old to use this product. Minors are prohibited to use this product alone, so as to avoid injury. ● It is forbidden to use parts other than the metal rod of the host in the liquid to avoid circuit damage. ● Product built-in li-ion battery, if not often used, please charge once every two months. MAINTENANCE ● Please wipe the lens with a lens brush or soft cloth.…

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Attestation Statements

Rev 1/26/2023 ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 03-20-2026 Ref: Attestation Statements Part 2.911(d)(5)(i) Filing FCC ID: 2BUQV-HS-OT10M [ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD.] certifies that the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. [ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD.] certifies that the equipment for which authorization is sought does not include cybersecurity or anti-virus software produced or provided by Kaspersky Lab, Inc. or any of its successors and assignees, including equipment with integrated Kaspersky Lab, Inc. (or any of its successors and assignees) cybersecurity or anti-virus software pursuant to DA-24- 886 and KDB 986446 D01 Covered Equipment Guidance section B(2a). Device is inherently compliant based on hardware limitations or software controls. or A Software Bill of Materials (SBOM) is provided to the TCB for review, and The end-user or third parties cannot install additional software on this device. Sincerely, (Applicant signature) (Applicant printed name) Jinshan Wang Rev 1/26/2023 ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 03-20-2026 Ref: Attestation Statements Part 2.911(d)(5)(ii) Filing FCC ID: 2BUQV-HS-OT10M [ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD.] ce8rtifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List (as a specifically named entity or any of its subsidiaries or affiliates) as an entity producing “covered” equipment. Sincerely, (Applicant signature) (Applicant printed name) Jinshan Wang

Attestation Statements

ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. U.S. Agent Letter of Attestation To: Federal Communications Commission 7435 Oakland Mills Road, Columbia, MD 21046, USA Date: March 20, 2026 Ref: Attestation Statement – Part 2.911(d)(7) filing FCC ID: 2BUQV-HS-OT10M ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. (“the applicant”) certifies that, as of the date of the filing of the application, CLF Import and Export Limited (“the agent”) is our designated U.S. agent for service of process for the above reference FCC ID. The applicant accepts to maintain an agent for service of process in the United States for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. The applicant further acknowledges it is our responsibility to inform the FCC whenever the agent information changes. CLF Import and Export Limited ("the agent) understand it is the agent's obligation to accept service of process in the United States for matters related to the applicable equipment, and at the physical U.S. address and email address. Designated U.S. Agent Company Name: CLF Import and Export Limited FRN: 0033489683 Address: 1312 17th Street #692, Denver, CO 80202, United States Signature: Contact Person: David Chen Tel: +1 949 254 2565 Email: [email protected] Applicant Company Name: ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. FRN: 0037965001 Address: Floor 2 & Floor3, Building 8 of Art & Crafts Park, Beiao Village, Sanjiang Street, Yongjia Country, Wenzhou City, Zhejiang Province, 325100, P.R. China Signature: Contact Person: Jinshan Wang Tel: +86 15040018389 Email: [email protected]

Cover Letter(s)

ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Date: February 4, 2026 Product Model Number: HS-OT10M FCC ID: 2BUQV-HS-OT10M To whom it may concern, Re: Product Certification Representative Authorization Letter We authorize QAI Laboratories Ltd. 3980 North Fraser Way, Burnaby B.C. Canada V5J 5K5 to act on our behalf on all matters concerning the above named equipment. This shall include the following: • Testing • Approval applications and procedures We declare that QAI Laboratories Ltd. is allowed to forward all information related to the approval project to the applied certification body and to the notification entities and to discuss any issues concerning the approval application. Any and all acts carried out by QAI Laboratories Ltd. on our behalf shall have the same effect as acts of our own. Signature: By: Jinshan Wang Title: Sales Manager Tel.: +86 15040018389 Email: [email protected] On behalf of: ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD.

Cover Letter(s)

ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA Date: March 20, 2026 Subject; Request for Confidentiality FCC ID: 2BUQV-HS-OT10M To Whom It May Concern, Pursuant to the provisions of the Commission’s rules Title 47 Sections §0.457 and §0.459, we are requesting the Commission to withhold the following attachment(s) as confidential documents from public disclosure indefinitely. These documents contain detailed system and equipment descriptions and are considered as proprietary information in operation of the equipment. The public disclosure of these documents might be harmful to our company and would give competitors an unfair advantage in the market. Schematic Diagram Block Diagram Parts List Operational Description Tune-up Procedure Software Security Requirements for UNII devices It is our understanding that all measurement test reports, FCC ID label format and correspondence during the certification review process cannot be granted as confidential documents and this information will be available for public review once the grant of equipment authorization is issued. Sincerely, Signature: By: Jinshan Wang Title: Sales Manager

External Photos

Report No: SSP26020084-1E FCC ID: 2BUQV-HS-OT10M Annex of Test Report Page 1 of 10 Annex A. EUT External Photos Model: HS-OT10M EUT View 1 EUT View 2 Report No: SSP26020084-1E FCC ID: 2BUQV-HS-OT10M Annex of Test Report Page 2 of 10 EUT View 3 EUT View 4 Report No: SSP26020084-1E FCC ID: 2BUQV-HS-OT10M Annex of Test Report Page 3 of 10 EUT View 5 EUT View 6 Report No: SSP26020084-1E FCC ID: 2BUQV-HS-OT10M Annex of Test Report Page 4 of 10 EUT View 7

ID Label/Location Info

Report No: SSP26020084-1E FCC ID: 2BUQV-HS-OT10M Annex of Test Report Page 10 of 10 Annex D. Label and Information FCC Label Sample Label Size: 2cm*1cm FCC Label Specifications Text is Black in color and is justified. Labels are printed in indelible ink on permanent adhesive backing or silk-screened onto the EUT or shall be affixed at a conspicuous location on the EUT. Where the EUT is constructed in two or more sections connected by wires and marketed together, the above statement is required to be affixed only to the main control unit. When the EUT is so small or for such use that it is not practicable to place the statement on it, the above information shall be placed in a prominent location in the instruction manual or pamphlet supplied to the user or, alternatively, shall be placed on the container in which the device is marketed. FCC Label Location

Internal Photos

Report No: SSP26020084-1E FCC ID: 2BUQV-HS-OT10M Annex of Test Report Page 5 of 10 Annex B. EUT Internal Photos EUT View 1 EUT View 2 Report No: SSP26020084-1E FCC ID: 2BUQV-HS-OT10M Annex of Test Report Page 6 of 10 EUT View 3 EUT View 4 SMD ANT Report No: SSP26020084-1E FCC ID: 2BUQV-HS-OT10M Annex of Test Report Page 7 of 10 EUT View 5 EUT View 6

RF Exposure Info

FCC ID: 2BUQV-HS-OT10M RF Exposure Evaluation According to KDB 447498 D01 General RF Exposure Guidance v06 and part 2.1093,Unless specifically required by the published RF exposure KDB procedures, standalone 1-g head or body and 10-g extremity SAR evaluation for general population exposure conditions, by measurement or numerical simulation, is not required when the corresponding SAR Test Exclusion Threshold condition(s), listed below, is (are) satisfied. For 100 MHz to 6 GHz and test separation distances ≤ 50 mm, the 1-g and 10-g SAR test exclusion thresholds are determined by the following: [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] · [√f(GHz)] ≤ 3.0 for 1-g SAR, and ≤ 7.5 for 10-g extremity SAR, where f(GHz) is the RF channel transmit frequency in GHz Power and distance are rounded to the nearest mW and mm before calculation The result is rounded to one decimal place for comparison Here, The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. For 2.4GWIFI Max Conducted Power(dBm) Tune-up Power(dBm) Max Tune-up Power(dBm) Max Power(mW) Frequency(MHz) Min. distance(mm) Calc. thresholds limit 7.24 7(±1) 8 6.31 2412 5 2.95996 3.0 So a SAR test is not required

Test Report

OA-C07 规格书 广州寒武纪电子科技有限公司 1 OA-C07_V01 SMD antenna specification sheet OverAir ® SMD The antenna series complies RoHS Specification PN: OA-C07 2.4 GHz ISM Band antenna OA-C07 规格书 广州寒武纪电子科技有限公司 2 OA-C07_V01 Features: 1. SMD patch antenna with dimensions of only 3.5 x 1.7 x 1.2 mm3 2. Low energy loss, high antenna efficiency. 3. High stability under temperature and humidity changes. Application: 1. 2.4GHz ISM band antenna application 2. Bluetooth, ZigBee, wireless applications, smart home applications, etc 3. WIFI (2.4G only). structure Size: Three views symb ol Dimension s (mm). L 3.5±0.2 w 1.7±0.1 T 1.2±0.1 a 0.4±0.1 不区分天线两端的馈电焊盘和固定焊盘 OA-C07 规格书 广州寒武纪电子科技有限公司 3 OA-C07_V01 Electrical characteristics OA-C07 Specification Working Frequency 2450±50MHz 带宽 Band Width >100MHz Impedance 50Ω Gain (dBi). 3.74(peak) VSWR <2 工作温度 Operation Temperature -40°C~+95°C 可承受功率 Power Capacity 3W The antenna 2.4G operating frequency needs to be achieved through impedance matching device debugging Antenna pad and trace design PCB schematic PCB design dimensional drawing OA-C07 规格书 广州寒武纪电子科技有限公司 4 OA-C07_V01 Matching device values Series Device Series 1 High frequency inductance 5.6nh Shunt 1 in parallel High OA-C07 规格书 广州寒武纪电子科技有限公司 5 OA-C07_V01 frequency inductance 4.7nh Series Device Series 2 Resistance 0Ω OA-C07 规格书 广州寒武纪电子科技有限公司 6 OA-C07_V01 Test the antenna test on the board (1.0mm thick). Antenna S11 characteristics Antenna VSWR characteristics OA-C07 规格书 广州寒武纪电子科技有限公司 7 OA-C07_V01 Efficiency and radiation diagram Efficiency, radiograph, gain and other properties are obtained based on the test board design. The specification test data for the OA-C07 antenna is based on the test PCB board size and the test orientation shown in the figure below. The following data was tested in an ETS 3D anechoic chamber Z Gain and efficiency Bandwidth 2.4G- 2.5GHz 峰值增益 Peak Gain 3.74dBi Average gain within the band Average Gain across the band 3.66dBi In-band gain range Gain Range across the band 3.42dBi~3.74dBi 峰值效率 Peak Efficiency 58.9% OA-C07 规格书 广州寒武纪电子科技有限公司 8 OA-C07_V01 Average efficiency within the band Average Efficiency across the band 55.9% OA-C07 规格书 广州寒武纪电子科技有限公司 9 OA-C07_V01 Theta @2.45 GHz Fees @2.45 GHz Total @2.45 GHz Welding conditions Typical welding specifications for reliable and non-destructive are shown in the figure below: 带内效率范围 Efficiency Range across the band 53.0%~58.9% OA-C07 规格书 广州寒武纪电子科技有限公司 10 OA-C07_V01 Packaging Plastic carrier tape specification (unit: mm). OA-C07 规格书 广州寒武纪电子科技有限公司 11 OA-C07_V01 Index By Bo FD T W Dimension (mm) 2.0±0.1 4.0±0.1 1.55±0.05 1.8±0.1 12±0.1 Index E F After P1 P2 Dimension (mm) 1.5±0.1 5.4±0.1 4.0±0.1 4.0±0.1 2.0±0.1 Reel size Index A B C Dimension(mm) 330 100 13.5 Standard Quantity: 2500 PCS/tray Storage environment The following conditions should be met when the product is stored: Temperature : - 10°C~+40°C Humidity : 30% to 70% Relative humidity The place where the product is placed should not come into contact with corrosive gases, such as sulfur, etc. Chlorine or acid may cause the product electrode to oxidize, resulting in poor weldability. The product should be placed in the toolbox and protected from moisture and dust. Products should be stored in warehouses and protected from heat, vibration, and direct sunlight. Products should be stored under closed conditions. 广州寒武纪电子科技有限公司 Business cooperation and technical support •Business cooperation: He Zhiling|Mobile phone13611498429WeChat:gzhwjelec [email protected] Liang Qijun|Mobile phone 18122043436WeChat:hwlec [email protected] •Technical consultation: Chen Gong | Mobile: 18028016875|WeChat: gzhanwuji [email protected] Company information •Guangzhou Cambrian Electronic Technology Co., Ltd •Address: 1101, 11th Floor, Building 1, Hongda Creative Park, Yuanxiang Road, Yunpu Street, Huangpu District, Guangzhou •http://www.gzhwjdz.com/

Test Report

Report No: SSP26020084-1E FCC Test Report Page 1 of 48 FCC TEST REPORT FCC ID: 2BUQV-HS-OT10M Report No. : SSP26020084-1E Applicant : ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Product Name : Video otoscope Model Name : HS-OT10M Test Standard : FCC Part 15.247 Date of Issue : 2026-03-14 Shenzhen CCUT Quality Technology Co., Ltd. 1F, Building 35, Changxing Technology Industrial Park, Yutang Street, Guangming District, Shenzhen, Guangdong, China; (Tel.:+86-755-23406590 website: www.ccuttest.com) This test report is limited to the above client company and the product model only. It may not be duplicated without prior permitted by Shenzhen CCUT Quality Technology Co., Ltd. Report No: SSP26020084-1E FCC Test Report Page 2 of 48 Test Report Basic Information Applicant..................................: ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Address of Applicant...............: Floor 2 & Floor3, Building 8 of Art & Crafts Park, Beiao Village, Sanjiang Street, Yongjia Country, Wenzhou City, Zhejiang Province, 325100, P.R. China Manufacturer..........................: ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Address of Manufacturer........: Floor 2 & Floor3, Building 8 of Art & Crafts Park, Beiao Village, Sanjiang Street, Yongjia Country, Wenzhou City, Zhejiang Province, 325100, P.R. China Product Name.........................: Video otoscope Brand Name.............................: - Main Model..............................: HS-OT10M Series Models..........................: - Test Standard..........................: FCC Part 15 Subpart C KDB 558074 D01 15.247 Meas Guidance v05r02 ANSI C63.4-2014 ANSI C63.10-2020 Date of Test .............................: 2026-03-04 to 2026-03-14 Test Result...............................: PASS Tested By ................................: (Colin Chen) Reviewed By............................: (Lorzix Luo) Authorized Signatory............: (Lahm Peng) Note : This test report is limited to the above client company and the product model only. It may not be duplicated without prior permitted by Shenzhen CCUT Quality Technology Co., Ltd.. All test data presented in this test report is only applicable to presented test sample. Report No: SSP26020084-1E FCC Test Report Page 3 of 48 CONTENTS 1. General Information ....................................................................................................................................................5 1.1 Product Information .............................................................................................................................................5 1.2 Test Setup Information..........................................................................................................................................6 1.3 Compliance Standards ...........................................................................................................................................7 1.4 Test Facilities ........................................................................................................................................................7 1.5 List of Measurement Instruments ..........................................................................................................................8 1.6 Measurement Uncertainty .....................................................................................................................................9 2. Summary of Test Results ........................................................................................................................................... 10 3. Antenna Requirement ............................................................................................................................................... 11 3.1 Standard and Limit.............................................................................................................................................. 11 3.2 Test Result .......................................................................................................................................................... 11 4. Conducted Emissions ................................................................................................................................................ 12 4.1 Standard and Limit.............................................................................................................................................. 12 4.2 Test Procedure.................................................................................................................................................... 12 4.3 Test Data and Results .......................................................................................................................................... 13 5. Radiated Emissions ................................................................................................................................................... 16 5.1 Standard and Limit.............................................................................................................................................. 16 5.2 Test Procedure.................................................................................................................................................... 16 5.3 Test Data and Results .......................................................................................................................................... 18 6. Band-edge Emissions(Radiated) ............................................................................................................................... 22 6.1 Standard and Limit.............................................................................................................................................. 22 6.2 Test Procedure.................................................................................................................................................... 22 6.3 Test Data and Results ......…

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Test Setup Photos

Report No: SSP26020084-1E FCC ID: 2BUQV-HS-OT10M Annex of Test Report Page 8 of 10 Annex C. Test Photos Radiated Emission Test View 1 Radiated Emission Test View 2 Report No: SSP26020084-1E FCC ID: 2BUQV-HS-OT10M Annex of Test Report Page 9 of 10 Conducted Emission Test View 1

Contact Information

Applicant

Jinshan Wang
[email protected]Fax: +86 15040018389

Technical Contact

CLF Import and Export LimitedDavid Chen
[email protected]

312 17th Street #692 · United States

Test Firm

Shenzhen CCUT Quality Technology Co., Ltd.Lahm Peng
[email protected]

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.41 GHz - 2.46 GHz5.30 mW
Confidentiality
Long Term
Grant Notes
Power listed is the maximum conducted output power.

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2BUQV-HS-OT10X

Video otoscope

Feb 10, 2026

Equipment Class

DTS - Digital Transmission System