510(k) K083371

NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) by Natus Medical, Inc. — Product Code GWF

K083371 is an FDA 510(k) premarket notification submitted by Natus Medical, Inc. for the device "NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)". The FDA issued a decision of Substantially Equivalent on December 8, 2009. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Natus Medical, Inc. has at least 10 other 510(k) clearances on record.