ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076

ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 is an FDA 510(k)-cleared medical device (K994330) manufactured by Aspect Medical Systems, 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 January 17, 2000. Regulation: 8.