
Tiara Medical Systems, Inc.
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TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530 is an FDA 510(k)-cleared medical device (K031935) 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 March 2, 2004. Regulation: 8.