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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 K220350
Device Name KardiaMobile 6L
Applicant
AliveCor, Inc.
189 N. Bernardo Ave.
Suite 100
Mountain View,  CA  94043
Applicant Contact Susan Noriega
Correspondent
Mdqr, LLC
189 N. Bernardo Ave.
Suite 100
Mountain View,  CA  94043
Correspondent Contact Prabhu Raghavan
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Codes
DPS   QDA  
Date Received02/07/2022
Decision Date 05/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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