510(k) clearance
Optiflow Oxygen Kit (AA484J)
- 510(k) number
- K262268
- Applicant
- Fisher and Paykel Healthcare Limited
- Decision date
- Aug 27, 2026
- Date received
- Jul 6, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- BTT
- Device type
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II
- Regulation
- 21 CFR 868.5450
- Advisory committee
- Anesthesiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Auckland, NZ