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Aspect Medical Systems, Inc.
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EEG MIS MONITOR MODEL # A-2000; BIS ENGINE is an FDA 510(k)-cleared medical device (K011534) 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 June 14, 2001. Regulation: 8.