K234053
- 510(k) number
- K234053
- Device name
- F&P Optiflow Flow Diverter
- Applicant
- Fisher & Paykel Healthcare, Ltd. NZ
- Product code
- CBP — Valve, Non-Rebreathing
- Decision date
- 2024-08-09
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K234053.pdf
Official FDA record: K234053
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.