Clearance Summary
AirSpiral Heated Breathing Tube received FDA 510(k) clearance under submission number K162553, sponsored by Fisher & Paykel Healthcare. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2018-12-20.
- Submission: K162553
- Applicant / Sponsor: Fisher & Paykel Healthcare
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5450
- Decision date: 2018-12-20
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.