AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000

AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 is an FDA 510(k)-cleared medical device (K072185) manufactured by Airistar Technologies, LLC. 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 26, 2008. Regulation: 8.