DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A

DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A is an FDA 510(k)-cleared medical device (K010616) manufactured by Hmi Industries, 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 March 27, 2001. Regulation: 8.