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Resmed, Ltd.
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RESMED S8 PRIME CPAP SYSTEM is an FDA 510(k)-cleared medical device (K033841) 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 9, 2004. Regulation: 8.