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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 K130409
Device Name ALIVECOR HEART MONITOR
Applicant
ALIVECOR, INC.
30 MAIDEN LANE, 6TH FLOOR
san francisco,  CA  94108
Applicant Contact michael righter
Correspondent
ALIVECOR, INC.
30 MAIDEN LANE, 6TH FLOOR
san francisco,  CA  94108
Correspondent Contact michael righter
Regulation Number870.2340
Classification Product Code
DPS  
Date Received02/19/2013
Decision Date 09/06/2013
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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