K241366
- 510(k) number
- K241366
- Device name
- QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
- Applicant
- Dehas Medical Systems GmbH DE
- Product code
- CBP — Valve, Non-Rebreathing
- Decision date
- 2024-10-29
- Date received
- 2024-05-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K241366.pdf
Official FDA record: K241366
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.