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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K241766
Device Name QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
Applicant
Fysicon BV
Hoogheuvelstraat 114
Oss,  NL 5349 BA
Applicant Contact Cornelis (Eric) Van Antwerpen
Correspondent
Trisler Consulting
306 Turnberry Ct.
Lebanon,  IN  46052
Correspondent Contact Patsy Trisler
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Code
DQK  
Date Received06/20/2024
Decision Date 08/27/2025
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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