510(k) K021801

BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS by Bio-Logic Systems Corp. — Product Code EWO

K021801 is an FDA 510(k) premarket notification submitted by Bio-Logic Systems Corp. for the device "BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS". The FDA issued a decision of Substantially Equivalent on June 27, 2002. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Bio-Logic Systems Corp. has at least 10 other 510(k) clearances on record.