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Draeger Medical AG & Co. Kgaa
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INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A is an FDA 510(k)-cleared medical device (K053204) manufactured by Draeger Medical AG & Co. Kgaa. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 2, 2006. Regulation: 8.