510(k) K990652

INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER by Idem (Int'L Dist. of Electronics For Medicine) — Product Code ETY

K990652 is an FDA 510(k) premarket notification submitted by Idem (Int'L Dist. of Electronics For Medicine) for the device "INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER". The FDA issued a decision of Substantially Equivalent on May 17, 1999. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090. Idem (Int'L Dist. of Electronics For Medicine) has at least 5 other 510(k) clearances on record.