K233821
- 510(k) number
- K233821
- Device name
- F&P Optiflow Oxygen Kit (AA451J)
- Applicant
- Fisher & Paykel Healthcare, Ltd. NZ
- Product code
- BTT — Humidifier, Respiratory Gas, (Direct Patient Interfa
- Decision date
- 2024-06-13
- Date received
- 2023-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233821.pdf
Official FDA record: K233821
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.