K243917
- 510(k) number
- K243917
- Device name
- F&P Optiflow Air/Oxygen Flow Source
- Applicant
- Fisher & Paykel Healthcare, Ltd. NZ
- Product code
- BZR — Mixer, Breathing Gases, Anesthesia Inhalation
- Decision date
- 2025-07-14
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K243917.pdf
Official FDA record: K243917
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.