AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)

AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) is an FDA 510(k)-cleared medical device (K960309) 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 February 27, 1997. Regulation: 8.