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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transmitters and receivers, electrocardiograph, telephone
510(k) Number K173872
Device Name FibriCheck
Qompium nv
Kempische Steenweg 311/27
Hasselt,  BE 3500
Applicant Contact Jo Van der Auwera
Qserve Group US Inc.
5600 Wisconsin Avenue
Chevy Chase,  MD  20815
Correspondent Contact Patsy Trisler
Regulation Number870.2920
Classification Product Code
Date Received12/20/2017
Decision Date 09/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No