DiscoverEEG System, Model DE-401

DiscoverEEG System, Model DE-401 is an FDA 510(k)-cleared medical device (K142834) manufactured by Neurowave 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 22, 2015. Regulation: 8.