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Draeger Medical GmbH
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SMARTPILOT VIEW MODEL MK04500 is an FDA 510(k)-cleared medical device (K103035) manufactured by Draeger Medical 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 March 27, 2012. Regulation: 8.