K262268
- 510(k) number
- K262268
- Device name
- Optiflow Oxygen Kit (AA484J)
- Applicant
- Fisher and Paykel Healthcare Limited NZ
- Product code
- BTT — Humidifier, Respiratory Gas, (Direct Patient Interfa
- Decision date
- 2026-08-27
- Date received
- 2026-07-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K262268.pdf
Official FDA record: K262268
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.