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2AYFHHP2Swallowable medical capsule to detect blood

Ovesco Endoscopy AG

Application Details

Equipment Class
DSC - Part 15 Security/Remote Control Transmitter
Date of Grant
Jul 04, 2024
Application Purpose
Original Equipment
Date of Application
Jul 04, 2024
Equipment Note
Swallowable medical capsule to detect blood
Frequency Range
434.42000000 - 434.42000000
Company
Ovesco Endoscopy AG
Country
Germany

Documents & Files

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Attestation Statements

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Cover Letter(s)

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ID Label/Location Info

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RF Exposure Info

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Test Report

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Document Text

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

RF Exposure Info

SAR Test exclusion documentation according to CFR 47 §1.1307, RSS-102 Report identification number: 1-5872-23-01-05_TR1-R01 Exemption (FCC) contains the module with the following certification numbers FCC ID 2AYFHHP2 This test report is electronically signed and valid without handwritten signature. For verification of the electronic signatures, the public keys can be requested at the testing laboratory. Document authorised: Alexander Hnatovskiy Marco Scigliano Lab Manager Testing Manager Radio Labs Radio Labs Test report no.: 1-5872-23-01-05_TR1-R01 © cetecom advanced GmbH Page 2 of 2 EUT technologies: Frequency / Range: Max. measured E.I.R.P: Qualified for 1mW blanket exemption (dBm) (μW) 434 MHz Proprietary -25.69 2.69 yes NOTES: For this calculation the EIRP was used instead of the conducted power as it represents the worst case scenario. Test results taken from cetecom advanced GmbH report 1-5872/23-01-03. Max Average power: 69.54 dBμV/m @3m = -25.69 dBmEIRP Blanket test exemption according CFR 47 §1.1307: §1.1307(b)(3)(i)(A) – A single RF source is exempt if the available maximum time-averaged power is no more than 1 mW, regardless of separation distance. (Applicable from 100 kHz to 100 GHz) Max. EIRP declared by manufacturer: < 0.1 mW (Qualified for blanket exemption) As the device is designed to be inside the human body for a time period, the following also applies: 3.3.4 Transmitters Implanted in the Body of a User As discussed in Section 2.1.2, when the aggregate of the maximum power available at the antenna port and radiating structures of an implanted transmitter, under all operating circumstances, is less than or equal to 1.0 mW, a SAR test exemption applies. Otherwise, a KDB inquiry is required to determine the appropriate SAR measurement or numerical simulation procedures, or both.

Test Report

00 1812AS/XXX-R15K-01 For customer approval26.04.16 T1447 3.00 max. 0.25~0.50 3.20 max 1. Core Material : Ceramic - 70 min.Q BG Ng 1 of 1 [email protected] This drawing is FASTRON exclusive property.Without the consent of Documentation Section this drawing may not be reproducrd or given to third party Page: Issue ISO [email protected]@fastrongroup.com www.fastrongroup.com [email protected] Date DateRev.Remarks Dimension in mm. Drawn by: Checked by: Approved by: Approved by: Part Name: Part Number: Valid when no tolerance is given: ± 0.1 Radius and chamfer ± 0.1 ± 0.5± 0.3± 0.2 ± 0.1 ± 0.1± 4  TEST INTRUMENT DCI ± 2 ± 1 1.00 A 100 MHz ± 0.5± 0.2 < 0.5>= 120 >= 30 < 30 >= 3 < 3 METRIC HI GBCDE FA 1 SW 13 12 11 10 9 8 7 6 5 4 3 2 ELECTRICAL REQUIREMENTS ITEM 150 nH ± 10%L(æ) Scale 10 : 1 UNITTEST FREQUENCY DCR >= 0.2>= 0.5 SRF 50 MHz - - max. 700 MHz min. < 120 >= 6 < 6 0.13 Note: Nizam 3.25 0.58 0.58 2.50 4.55 max. Fastron_Drawing_Antenna 1812AS R15K_T1447, Rev.1. Released 22.12.2021 via Ovesco CAQ system. Valid without signature.

Test Report

TEST REPORT Test report no.: 1-5872_23-01-0 3-A Testing laboratory Applicant cetecom advanced GmbH Untertuerkheimer Strasse 6 – 10 66117 Saarbruecken / Germany Phone: + 49 681 5 98 - 0 Fax: + 49 681 5 98 - 9075 Internet: https://cetecomadvanced.com e-mail: [email protected] Accredited Testing Laboratory: The testing laboratory (area of testing) is accredited according to DIN EN ISO/IEC 17025 (2018-03) by the Deutsche Akkreditierungsstelle GmbH (DAkkS). The accreditation is valid for the scope of testing procedures as stated in the accreditation certificate with the registration number: D-PL-12047-01-00. ISED Testing Laboratory Recognized Listing Number: DE0001 FCC designation number: DE0002 Ovesco Endoscopy AG Friedrich-Miescher-Straße 9 72076 Tübingen / GERMANY Phone: +49 7071 96528 160 Contact: Daniel Márquez Caraveo e-mail: [email protected] Manufacturer Ovesco Endoscopy AG Friedrich-Miescher-Straße 9 72076 Tübingen / GERMANY Test standard/s FCC - Title 47 CFR Part 15 FCC - Title 47 of the Code of Federal Regulations; Chapter I; Part 15 - Radio frequency devices RSS - 210 Issue 10 incl. Amendment Spectrum Management and Telecommunications Radio Standards Specification - Licence-Exempt Radio Apparatus: Category I Equipment For further applied test standards please refer to section 3 of this test report. Test Item Kind of test item: swallowable sensor capsule Model name: HemoPill acute FCC ID: 2AYFHHP2 Frequency: 434.42 MHz Technology tested: proprietary Antenna: Air core, intern Power supply: 4.18 V to 4.8 V DC by battery Temperature range: +10°C to +40°C This test report is electronically signed and valid without handwritten signature. For verification of the electronic signatures, the public keys can be requested at the testing laboratory. Test report authorized: Test performed: Christoph Schneider Hans-Joachim Wolsdorfer Lab Manager Lab Manager Radio Labs Radio Labs Test report no.: 1-5872_23-01-03-A © cetecom advanced GmbH Page 2 of 30 1 Table of contents 1 Table of contents ....................................................................................................................................... 2 2 General information ................................................................................................................................... 3 2.1 Notes and disclaimer ...................................................................................................................... 3 2.2 Application details .......................................................................................................................... 3 2.3 Test laboratories sub-contracted .................................................................................................... 3 3 Test standard/s, references and accreditations ......................................................................................... 4 4 Reporting statements of conformity – decision rule .................................................................................. 5 5 Test environment ....................................................................................................................................... 6 6 Test item ................................................................................................................................................... 6 6.1 General description ......................................................................................................................... 6 6.2 Additional information .................................................................................................................... 6 7 Description of the test setup ...................................................................................................................... 7 7.1 Shielded semi anechoic chamber .................................................................................................... 8 7.2 Shielded fully anechoic chamber ................................................................................................... 10 7.3 Conducted measurements ............................................................................................................ 11 8 Sequence of testing ................................................................................................................................. 12 8.1 Sequence of testing radiated spurious 9 kHz to 30 MHz ............................................................... 12 8.2 Sequence of testing radiated spurious 30 MHz to 1 GHz ............................................................... 13 8.3 Sequence of testing radiated spurious 1 GHz to 18 GHz................................................................ 14 9 Measurement uncertainty ........................................................................................................................ 15 10 Summary of measurement results ....................................................................................................... 16 10.1 Additional comments ................................................................................................................. 16 11 Measurement results ........................................................................................................................... 17 11.1 Timing of the transmitter ........................................................................................................... 17 11.2 Emission bandwidth .................................................................................................................. 19 11.3 Field strength of the fundamental .............................................................................................. 21 11.4 Field strength of the harmonics and spurious ............................................................................ 23 12 Observations .............................................................................................................…

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Contact Information

Applicant

Christoph Damm(Head of Quality Management & Regulatory Affairs)
[email protected]+49707196528Fax: +49707196528260

Test Firm

cetecom advanced GmbHGerald Schmidt
[email protected]49-681-598-0Fax: 49-681-598-8775

Technical Specifications

#Rule PartsFrequency RangePower Output
115.231(e)434.42 MHz - 434.42 MHz-
Confidentiality
Long Term

Other Applications from Ovesco Endoscopy AG

HemoPill acute - FCC ID 2AYFH-OVE-HP - Ovesco Endoscopy AG
2AYFH-OVE-HP

HemoPill acute

Mar 23, 2021

Equipment Class

DXX - Part 15 Low Power Communication Device Transmitter