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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name photoplethysmograph analysis software for over-the-counter use
510(k) Number K212372
Device Name Fitbit Irregular Rhythm Notifications
Applicant
Fitbit Inc
199 Fremont Street 14th Floor
San Francisco,  CA  94105
Applicant Contact Randy Parry
Correspondent
Fitbit Inc
199 Fremont Street 14th Floor
San Francisco,  CA  94105
Correspondent Contact Randy Parry
Regulation Number870.2790
Classification Product Code
QDB  
Date Received07/30/2021
Decision Date 04/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04380415
Reviewed by Third Party No
Combination Product No
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