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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
510(k) Number K232804
Device Name FibriCheck
Applicant
Qompium NV
Kempische Steenweg 303/27
Hasselt,  BE 3500
Applicant Contact Jo Van der Auwera
Correspondent
Qompium NV
Kempische Steenweg 303/27
Hasselt,  BE 3500
Correspondent Contact Jo Van der Auwera
Regulation Number870.2785
Classification Product Code
QME  
Subsequent Product Code
DXH  
Date Received09/12/2023
Decision Date 06/07/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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