EEG-4300 W/OPTINAL ACCESS. EEG 4314 &

EEG-4300 W/OPTINAL ACCESS. EEG 4314 & is an FDA 510(k)-cleared medical device (K842714) manufactured by Nihon Kohden America, 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 September 24, 1984. Regulation: 8.