Clearance Summary
DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A received FDA 510(k) clearance under submission number K010616, sponsored by Hmi Industries, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2001-03-28.
- Submission: K010616
- Applicant / Sponsor: Hmi Industries, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5045
- Decision date: 2001-03-28
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.