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Cortex Biophysik GmbH
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CORTEX METAMAX is an FDA 510(k)-cleared medical device (K001631) manufactured by Cortex Biophysik 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 February 21, 2001. Regulation: 8.