Clearance Summary
NORELCO CLEAN AIR SYSTEM MODEL CAM665 received FDA 510(k) clearance under submission number K942686, sponsored by Norelco Consumer Products Co.. 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 1994-10-07.
- Submission: K942686
- Applicant / Sponsor: Norelco Consumer Products Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5045
- Decision date: 1994-10-07
Classification & Regulation
This clearance is catalogued under FDA product code FRF and 21 CFR 880.5045, within the General Hospital review panel as a Class II device.