AIRPILOTMASK, MODEL TMS-900

AIRPILOTMASK, MODEL TMS-900 is an FDA 510(k)-cleared medical device (K992192) manufactured by Tiara Medical Systems, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 11, 2000. Regulation: 8.