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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Outpatient Cardiac Telemetry
510(k) Number K160064
FOIA Releasable 510(k) K160064
Device Name MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
Applicant
Infobionic, Inc.
600 Suffolk St.
Lowell,  MA  01854
Applicant Contact NANCY BRIEFS
Correspondent
Infobionic, Inc.
600 Suffolk St.
Lowell,  MA  01854
Correspondent Contact CARRIE NEUBERGER
Regulation Number870.1025
Classification Product Code
QYX  
Subsequent Product Code
DSI  
Date Received01/13/2016
Decision Date 03/11/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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