ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG

ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG is an FDA 510(k)-cleared medical device (K002631) manufactured by Eemagine Medical Imaging Solutions GmbH. 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 22, 2000. Regulation: 8.