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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 K142743
Device Name AliveCor Heart Monitor
Applicant
AliveCor, Inc.
30 Maiden Lane, 6th Floor
San Francisco,  CA  94108
Applicant Contact Albert Boniske
Correspondent
AliveCor, Inc.
30 Maiden Lane, 6th Floor
San Francisco,  CA  94108
Correspondent Contact Albert Boniske
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Code
DPS  
Date Received09/24/2014
Decision Date 01/27/2015
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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