
Siemens Elema AB
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KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E is an FDA 510(k)-cleared medical device (K010923) manufactured by Siemens Elema AB. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 22, 2002. Regulation: 8.