510(k) K930003

TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES by Etymotic Research — Product Code EWO

K930003 is an FDA 510(k) premarket notification submitted by Etymotic Research for the device "TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES". The FDA issued a decision of Substantially Equivalent on June 18, 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.