Clearance Summary
REVOLUTIONFULL FACE MASK received FDA 510(k) clearance under submission number K082866, sponsored by Respironics Inc., Sleep & Home Respiratory Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2009-01-30.
- Submission: K082866
- Applicant / Sponsor: Respironics Inc., Sleep & Home Respiratory Group
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2009-01-30
Classification & Regulation
This clearance is catalogued under FDA product code BZD and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.