Clearance Summary
RXAIR 3000 received FDA 510(k) clearance under submission number K951981, sponsored by Clean Air Research & Development. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1995-10-12.
- Submission: K951981
- Applicant / Sponsor: Clean Air Research & Development
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6500
- Decision date: 1995-10-12
Classification & Regulation
This clearance is catalogued under FDA product code FRA and 21 CFR 880.6500, within the General Hospital review panel as a Class II device.