Clearance Summary
AIR-ELECTRONIC AIR CLEANER (FILTER) received FDA 510(k) clearance under submission number K884472, sponsored by White-Rodgers, Div. Emerson Electric 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 1989-01-19.
- Submission: K884472
- Applicant / Sponsor: White-Rodgers, Div. Emerson Electric Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5045
- Decision date: 1989-01-19
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.