FDA 510(k)

QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)

K-Number: K241766 · 2025-08-27

Decision Date2025-08-27

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) is a medical device manufactured by Fysicon BV. It received FDA 510(k) clearance on 2025-08-27 under approval number K241766. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)?

QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) is a medical device that received FDA 510(k) clearance on 2025-08-27. It is manufactured by Fysicon BV. The 510(k) number is K241766.

When was QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) approved by the FDA?

QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) received FDA 510(k) clearance on 2025-08-27, under approval number K241766.

What company makes QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)?

QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) is manufactured by Fysicon BV.

What is the FDA product code for QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)?

The FDA product code for QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) is MWI.

Other Devices by Fysicon BV

K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.