NEUROFAX, MODELS EEG-1100A, EEG-9100A

NEUROFAX, MODELS EEG-1100A, EEG-9100A is an FDA 510(k)-cleared medical device (K011204) 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 May 7, 2001. Regulation: 8.