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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, programmable
510(k) Number K212662
Device Name AliveCor QT Service
AliveCor, Inc.
189 N Bernardo Ave., Suite 100
Mountain View,  CA  94043
Applicant Contact Susan Noriega
189 N. Bernardo Ave
Suite 100
Mountain View,  CA  94043
Correspondent Contact Prabhu Raghavan
Regulation Number870.1425
Classification Product Code
Subsequent Product Code
Date Received08/23/2021
Decision Date 04/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No