
GE Healthcare
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DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES. is an FDA 510(k)-cleared medical device (K051883) manufactured by GE Healthcare. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 4, 2005. Regulation: 8.