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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 K201985
Device Name KardiaAI
Applicant
AliveCor, Inc.
444 Castro Street, Suite 600
Mountain View,  CA  94041
Applicant Contact Saket Bhatt
Correspondent
MDQR, LLC
444 Castro Street, Suite 600
Mountain View,  CA  94041
Correspondent Contact Prabhu Raghavan
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DPS  
Date Received07/17/2020
Decision Date 11/12/2020
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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