
Draeger Medical AG & Co. KG
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EVITE XL is an FDA 510(k)-cleared medical device (K083050) manufactured by Draeger Medical AG & Co. KG. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 28, 2008. Regulation: 8.