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FDA 510(k) K160064, MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System, by Infobionic, Inc.

FDA 510(k) K160064, MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System, by Infobionic, Inc.

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510(K) Number: K160064
Device Name: MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
Manufacturer: Infobionic, Inc.
Device Classification Name: Outpatient Cardiac Telemetry
Regulation Number: QYX
Classification Product Code: KXA
Date Received: 01/13/2016
Decision Date: 03/11/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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