40-HZ AUDITORY EVOKED RESPONSE TEST

40-HZ AUDITORY EVOKED RESPONSE TEST is an FDA 510(k)-cleared medical device (K862361) manufactured by Cadwell Laboratories, 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 September 16, 1986. Regulation: 8.