iCEWav Neuromonitoring Platform

iCEWav Neuromonitoring Platform is an FDA 510(k)-cleared medical device (K191868) manufactured by Ice Neurosystems, 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 March 30, 2020. Regulation: 8.