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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 K182456
Device Name Study Watch
Applicant
Verily Life Sciences LLC
269 E Grand Avenue
South San Francisco,  CA  94080
Applicant Contact Shilpa Mydur
Correspondent
Verily Life Sciences LLC
269 E Grand Avenue
South San Francisco,  CA  94080
Correspondent Contact Shilpa Mydur
Regulation Number870.2920
Classification Product Code
DXH  
Date Received09/07/2018
Decision Date 01/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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