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Drager Medizintechnik GmbH
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OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 is an FDA 510(k)-cleared medical device (K023289) manufactured by Drager Medizintechnik GmbH. 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 14, 2003. Regulation: 8.