510(k) K890124

ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER by Grason-Stadler, Inc. — Product Code EWO

K890124 is an FDA 510(k) premarket notification submitted by Grason-Stadler, Inc. for the device "ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER". The FDA issued a decision of Substantially Equivalent on July 14, 1989. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Grason-Stadler, Inc. has at least 10 other 510(k) clearances on record.