510(k) K012549

ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM by Healthway Products, Inc. — Product Code FRF

K012549 is an FDA 510(k) premarket notification submitted by Healthway Products, Inc. for the device "ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 4, 2002. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.