K241766
- 510(k) number
- K241766
- Device name
- QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
- Applicant
- Fysicon BV NL
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2025-08-27
- Date received
- 2024-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K241766.pdf
Official FDA record: K241766
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.