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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph
510(k) Number K122356
Device Name ALIVECOR HEART MONITOR FOR IPHONE
Original Applicant
ALIVECOR, INC.
140 geary street
suite 500
san francisco,  CA  94108
Original Contact michael righter
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/03/2012
Decision Date 11/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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