510(k) K011181

ICS MEDICAL CHARTR OAE WITH TYMP by Ics Medical Corp. — Product Code EWO

K011181 is an FDA 510(k) premarket notification submitted by Ics Medical Corp. for the device "ICS MEDICAL CHARTR OAE WITH TYMP". The FDA issued a decision of Substantially Equivalent on June 25, 2001. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Ics Medical Corp. has at least 10 other 510(k) clearances on record.