510(k) K930553

CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT by Etymotic Research — Product Code EWO

K930553 is an FDA 510(k) premarket notification submitted by Etymotic Research for the device "CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT". The FDA issued a decision of Substantially Equivalent on September 29, 1993. 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.