Clearance Summary
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version received FDA 510(k) clearance under submission number K173060, sponsored by Fisher and Paykel Healthcare Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2018-01-25.
- Submission: K173060
- Applicant / Sponsor: Fisher and Paykel Healthcare Limited
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5895
- Decision date: 2018-01-25
Classification & Regulation
This clearance is catalogued under FDA product code CBK and 21 CFR 868.5895, within the Anesthesiology review panel as a Class II device.