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Fysicon BV
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K241766
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
August 27, 2025
K170032
QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP
September 8, 2017