510(k) K991853

INTERACOUSTICS EP 15 ABR STAND ALONE UNIT by Idem (Int'L Dist. of Electronics For Medicine) — Product Code GWJ

K991853 is an FDA 510(k) premarket notification submitted by Idem (Int'L Dist. of Electronics For Medicine) for the device "INTERACOUSTICS EP 15 ABR STAND ALONE UNIT". The FDA issued a decision of Substantially Equivalent on October 25, 1999. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Idem (Int'L Dist. of Electronics For Medicine) has at least 5 other 510(k) clearances on record.