HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C

HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C is an FDA 510(k)-cleared medical device (K984116) manufactured by Abatement Technologies, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 1999. Regulation: 8.