
Aspect Medical Systems, Inc.
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EEG MONITOR WITH BIS, MODEL A-2000 is an FDA 510(k)-cleared medical device (K030267) 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 14, 2004. Regulation: 8.