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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
Applicant
Qompium nv
Kempische Steenweg 311/27
hasselt,  BE 3500
Applicant Contact jo van der auwera
Correspondent
Qserve Group US Inc.
5600 Wisconsin Avenue
chevy chase,  MD  20815
Correspondent Contact patsy trisler
Regulation Number870.2920
Classification Product Code
DXH  
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
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