510(k) K234058
F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) by
Fisher &Paykel Healthcare , Ltd.
— Product Code BTT
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2024
- Date Received
- December 22, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5450
- Review Panel
- AN
- Submission Type