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Drager Medical AG & Co. Kgaa
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OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500 is an FDA 510(k)-cleared medical device (K072412) manufactured by Drager 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 5, 2008. Regulation: 8.