
Datex-Ohmeda, Inc.
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DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES is an FDA 510(k)-cleared medical device (K000892) manufactured by Datex-Ohmeda, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 2000. Regulation: 8.