NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300

NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 is an FDA 510(k)-cleared medical device (K905594) 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 June 27, 1991. Regulation: 8.