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Somnomedics GmbH
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SOMNOSCREEN EEG10-20 is an FDA 510(k)-cleared medical device (K071556) manufactured by Somnomedics 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 July 17, 2007. Regulation: 8.