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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
Model AC-001
Device Name ALIVECOR HEART MONITOR FOR IPHONE
Applicant
ALIVECOR, INC.
140 geary street
suite 500
san francisco,  CA  94108
Contact michael righter
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/03/2012
Decision Date 11/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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