Class Class II
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) (K241766)
Description
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) by Fysicon BV, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241766
Clearance Date2025-08-27
Clearance TypeTraditional
Product CodeMWI
Regulation Number870.2300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241766
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) (K241766) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP... | Fysicon BV | 2017 |
| K131497 | MCKESSON CARDIOLOGY HEMO | Mckesson Israel , Ltd. | 2013 |
Trace the full predicate network for K241766
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.