DUAL CHENNEL BRAIN ACTIVITY MONITOR

DUAL CHENNEL BRAIN ACTIVITY MONITOR is an FDA 510(k)-cleared medical device (K843808) manufactured by Datex Division Instrumentarium 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 November 7, 1984. Regulation: 8.