510(k) K031986

ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS by Ics Medical — Product Code EWO

K031986 is an FDA 510(k) premarket notification submitted by Ics Medical for the device "ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS". The FDA issued a decision of Substantially Equivalent on July 24, 2003. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Ics Medical has at least 10 other 510(k) clearances on record.