ELECTROENCEPHALOGRAPH ACCUTRACE 100

ELECTROENCEPHALOGRAPH ACCUTRACE 100 is an FDA 510(k)-cleared medical device (K781041) manufactured by Beckman Instruments, 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, 1978. Regulation: 8.