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FDA 510(k)

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

K-Number: K241766 · 2025-08-27

ApplicantFysicon BV
Decision Date2025-08-27
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) is the device name listed in this FDA 510(k) record. The listed applicant is Fysicon BV. It received FDA 510(k) clearance on 2025-08-27 under 510(k) 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. The listed applicant is Fysicon BV. The 510(k) number is K241766.

When did QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) receive FDA 510(k) clearance?

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

Who is the listed applicant for QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)?

The FDA 510(k) record lists Fysicon BV as the applicant. This does not by itself establish the device manufacturer.

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 records listing Fysicon BV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.

Official Source

View on FDA Database →

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

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