NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)

NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) is an FDA 510(k)-cleared medical device (K083371) manufactured by Natus Medical, 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 7, 2009. Regulation: 8.