510(k) K241766

QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) by Fysicon BV — Product Code MWI

K241766 is an FDA 510(k) premarket notification submitted by Fysicon BV for the device "QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)". The FDA issued a decision of Substantially Equivalent on August 27, 2025. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Fysicon BV has at least 1 other 510(k) clearance on record.