Clearance Summary
F&P Optiflow Oxygen Kit (AA451J) received FDA 510(k) clearance under submission number K233821, sponsored by Fisher & Paykel Healthcare, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2024-06-13.
- Submission: K233821
- Applicant / Sponsor: Fisher & Paykel Healthcare, Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5450
- Decision date: 2024-06-13
Classification & Regulation
This clearance is catalogued under FDA product code BTT and 21 CFR 868.5450, within the Anesthesiology review panel as a Class II device.