NEUROFAX, MODEL EEG-1100A

NEUROFAX, MODEL EEG-1100A is an FDA 510(k)-cleared medical device (K992742) 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 October 13, 1999. Regulation: 8.