
Tiara Medical Systems, Inc.
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TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 is an FDA 510(k)-cleared medical device (K043382) 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 January 18, 2005. Regulation: 8.