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

K984116 is an FDA 510(k) premarket notification submitted by Abatement Technologies, Inc. for the device "HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C". The FDA issued a decision of Substantially Equivalent on June 24, 1999. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.