NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A

NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A is an FDA 510(k)-cleared medical device (K080546) 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 August 28, 2008. Regulation: 8.