510(k) K092373

ICS CHARTR EP 200 by Gn Otometrics — Product Code GWJ

K092373 is an FDA 510(k) premarket notification submitted by Gn Otometrics for the device "ICS CHARTR EP 200". The FDA issued a decision of Substantially Equivalent on September 3, 2009. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Gn Otometrics has at least 10 other 510(k) clearances on record.