2AAUFSPS003

Application Details

Equipment Class: 8CC - Part 18 Consumer Device
Date of Grant: Oct 04, 2022
Application Purpose: Original Equipment
Date of Application: Oct 04, 2022
Equipment Note: SpiroSphere is a diagnostic compact device to measure inspiratory and expiratory lung function parameters
Frequency Range: 0.11200000 - 0.30000000
Company: eResearchTechnology GmbH
Country: Germany

Documents & Files

Select a file to view

Users Manual

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2aaufsps003-usersmanual-6151023.pdf

10/04/2022•2.38 MB•PDF

Cover Letter(s)

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2aaufsps003-coverletters-6151013.pdf

10/04/2022•195.12 KB•PDF

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2aaufsps003-coverletters-6151014.pdf

10/04/2022•90.80 KB•PDF

External Photos

ID Label/Location Info

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2aaufsps003-idlabellocationinfo-6151015.pdf

10/04/2022•421.94 KB•PDF

Internal Photos

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2aaufsps003-internalphotos-6151017.pdf

10/04/2022•2.95 MB•PDF

RF Exposure Info

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2aaufsps003-rfexposureinfo-6151025.pdf

10/04/2022•806.56 KB•PDF

Test Report

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2aaufsps003-testreport-6153295.pdf

10/06/2022•4.96 MB•PDF

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2aaufsps003-testreport-6153296.pdf

10/06/2022•2.75 MB•PDF

Test Setup Photos

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2aaufsps003-testsetupphotos-6151018.pdf

10/04/2022•1.41 MB•PDF

Contact Information

Applicant Contact Person

Name: Juergen Kasprowitsch
Title: Director, Quality Management
Email: [email protected]
Phone: 0049 9305 720
Fax: 0049 9305 720 7170

Technical Contact

Firm Name: eResearchTechnology GmbH
Name: Bernd Mark
Email: [email protected]
Phone: +49 9305720 6194
Address: Sieboldstrasse 3
Estenfeld, 97230
Germany

Test Firm

Firm Name: Eurofins Product Service GmbH
Name: Michael Howard
Email: [email protected]
Phone: 49-33631-888-300

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Application Purpose

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