510(k) K981327

INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER by Idem (Int'L Dist. of Electronics For Medicine) — Product Code EWO

K981327 is an FDA 510(k) premarket notification submitted by Idem (Int'L Dist. of Electronics For Medicine) for the device "INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER". The FDA issued a decision of Substantially Equivalent on May 11, 1998. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Idem (Int'L Dist. of Electronics For Medicine) has at least 5 other 510(k) clearances on record.