510(k) K011114

ETYMOTIC RESEARCH ER-10D OAE PROBE by Etymotic Research — Product Code EWO

K011114 is an FDA 510(k) premarket notification submitted by Etymotic Research for the device "ETYMOTIC RESEARCH ER-10D OAE PROBE". The FDA issued a decision of Substantially Equivalent on July 3, 2001. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Etymotic Research has at least 10 other 510(k) clearances on record.