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FDA 510(k) K130921, ALIVECOR HEART MONITOR OTC, by AliveCor, Inc.

FDA 510(k) K130921, ALIVECOR HEART MONITOR OTC, by AliveCor, Inc.

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510(K) Number: K130921
Device Name: ALIVECOR HEART MONITOR OTC
Manufacturer: AliveCor, Inc.
Device Classification Name: Electrocardiograph
Regulation Number: DPS
Classification Product Code: KXA
Date Received: 04/03/2013
Decision Date: 02/06/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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