510(k) K083861

TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE by Interacoustics AS — Product Code ETY

K083861 is an FDA 510(k) premarket notification submitted by Interacoustics AS for the device "TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE". The FDA issued a decision of Substantially Equivalent on April 9, 2009. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090. Interacoustics AS has at least 10 other 510(k) clearances on record.