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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 K213357
Device Name Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
Applicant
Verily Life Sciences LLC
269 East Grand Avenue
South San Francisco,  CA  94080
Applicant Contact Dinesh Puppala
Correspondent
Verily Life Sciences LLC
269 East Grand Avenue
South San Francisco,  CA  94080
Correspondent Contact Dinesh Puppala
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Code
DPS  
Date Received10/12/2021
Decision Date 07/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04546763
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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