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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 K170032
Device Name QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP
Applicant
Fysicon BV
Hoogheuvelstraat 114
Oss,  NL 5349 BA
Applicant Contact C.W.A (Eric) Van Antwerpen
Correspondent
Qserve Group US Inc.
5600 Wisconsin Avenue
Chevy Chase,  MD  20815
Correspondent Contact Patsy J. Trisler
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Code
DQK  
Date Received01/04/2017
Decision Date 09/08/2017
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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