K234058
- 510(k) number
- K234058
- Device name
- F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
- Applicant
- Fisher & Paykel Healthcare, Ltd. NZ
- Product code
- BTT — Humidifier, Respiratory Gas, (Direct Patient Interfa
- Decision date
- 2024-08-08
- Date received
- 2023-12-22
- 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: K234058.pdf
Official FDA record: K234058
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.