510(k) K984116
HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C by
Abatement Technologies, Inc.
— Product Code FRF
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1999
- Date Received
- November 17, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleaner, Air, Medical Recirculating
- Device Class
- Class II
- Regulation Number
- 880.5045
- Review Panel
- HO
- Submission Type