MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY

MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY is an FDA 510(k)-cleared medical device (K001013) manufactured by Airsep Corp.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 15, 2000. Regulation: 8.