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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 K133753
Device Name MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR
Applicant
INFOBIONIC, INC.
600 SUFFOLK STREET
P.O. BOX 9719
LOWELL,  MA  01853
Applicant Contact CARRIE NEUBERGER
Correspondent
INFOBIONIC, INC.
600 SUFFOLK STREET
P.O. BOX 9719
LOWELL,  MA  01853
Correspondent Contact CARRIE NEUBERGER
Regulation Number870.1025
Classification Product Code
QYX  
Subsequent Product Codes
DSI   MLO  
Date Received12/09/2013
Decision Date 09/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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