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Resmed, Ltd.
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MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL) is an FDA 510(k)-cleared medical device (K100772) 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 June 8, 2010. Regulation: 8.