NEUROFAX EEG 5532

NEUROFAX EEG 5532 is an FDA 510(k)-cleared medical device (K915096) 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 March 10, 1992. Regulation: 8.