SPECTRAL EEG MONITOR MODEL A1000

SPECTRAL EEG MONITOR MODEL A1000 is an FDA 510(k)-cleared medical device (K923043) 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 December 2, 1992. Regulation: 8.