BrainScope TBI (Model: Ahead 400)

BrainScope TBI (Model: Ahead 400) is an FDA 510(k)-cleared medical device (K183241) manufactured by Brainscope Company, 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 February 18, 2019. Regulation: 8.