510(k) K083399

ICS CHARTR EP 200 by Gn Otometrics A/S — Product Code GWJ

K083399 is an FDA 510(k) premarket notification submitted by Gn Otometrics A/S for the device "ICS CHARTR EP 200". The FDA issued a decision of Substantially Equivalent on February 20, 2009. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Gn Otometrics A/S has at least 10 other 510(k) clearances on record.