A-2000 EEG MONITOR WITH BIS

A-2000 EEG MONITOR WITH BIS is an FDA 510(k)-cleared medical device (K974496) 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 February 5, 1998. Regulation: 8.