510(k) K994254

INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER by International Distributors of Electronics For Medi — Product Code ETY

K994254 is an FDA 510(k) premarket notification submitted by International Distributors of Electronics For Medi for the device "INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER". The FDA issued a decision of Substantially Equivalent on March 14, 2000. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090.