MULTI-SIGNAL AUDITORY STIMULATOR SM700

MULTI-SIGNAL AUDITORY STIMULATOR SM700 is an FDA 510(k)-cleared medical device (K830579) manufactured by Nicolet Biomedical Instruments. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 7, 1983. Regulation: 8.