MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100

MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 is an FDA 510(k)-cleared medical device (K023693) manufactured by Airex, 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 11, 2003. Regulation: 8.