510(k) K002985

ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS by Ics Medical Corp. — Product Code GWJ

K002985 is an FDA 510(k) premarket notification submitted by Ics Medical Corp. for the device "ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 13, 2000. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Ics Medical Corp. has at least 10 other 510(k) clearances on record.