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Datex-Ohmeda
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DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES is an FDA 510(k)-cleared medical device (K023459) manufactured by Datex-Ohmeda. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 12, 2003. Regulation: 8.