SPECTRAL EEG MONITOR MODEL B500

SPECTRAL EEG MONITOR MODEL B500 is an FDA 510(k)-cleared medical device (K913051) manufactured by Biometrak Corp.. 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 19, 1991. Regulation: 8.