510(k) K022728

AUDIOTRAVELLER, MODEL AA222 by Interacoustics A/S, Assens — Product Code ETY

K022728 is an FDA 510(k) premarket notification submitted by Interacoustics A/S, Assens for the device "AUDIOTRAVELLER, MODEL AA222". The FDA issued a decision of Substantially Equivalent on October 11, 2002. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090. Interacoustics A/S, Assens has at least 3 other 510(k) clearances on record.