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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transmitters and receivers, electrocardiograph, telephone
510(k) Number K192415
Device Name Study Watch with Irregular Pulse Monitor
Applicant
Verily Life Sciences LLC
269 E Grand Avenue
South San Francisco,  CA  94080
Applicant Contact Connie Pascual
Correspondent
Verily Life Sciences LLC
269 E Grand Avenue
South San Francisco,  CA  94080
Correspondent Contact Richard M. Stewart
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Code
DPS  
Date Received09/04/2019
Decision Date 01/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04074434
Reviewed by Third Party No
Combination Product No
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