AIRSEP NEWLIFE AIR OUTLET OPTION

AIRSEP NEWLIFE AIR OUTLET OPTION is an FDA 510(k)-cleared medical device (K944020) manufactured by Airsep Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 1995. Regulation: 8.