510(k) K010616

DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A by Hmi Industries, Inc. — Product Code FRF

K010616 is an FDA 510(k) premarket notification submitted by Hmi Industries, Inc. for the device "DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A". The FDA issued a decision of Substantially Equivalent on March 28, 2001. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045. Hmi Industries, Inc. has at least 2 other 510(k) clearances on record.