Clearance Summary
HUNTER AIR CLEANERS MODEL NOS. 30100/30250/30300 received FDA 510(k) clearance under submission number K930420, sponsored by Hunter Fan 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 1993-09-23.
- Submission: K930420
- Applicant / Sponsor: Hunter Fan Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5045
- Decision date: 1993-09-23
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.