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Delphi Medical Systems
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PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 is an FDA 510(k)-cleared medical device (K073242) manufactured by Delphi Medical Systems. 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 2, 2008. Regulation: 8.