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Resmed, Ltd.
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RES TRAXX ONLINE, MODEL: R14 is an FDA 510(k)-cleared medical device (K083816) manufactured by Resmed, Ltd.. 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 19, 2009. Regulation: 8.