510(k) K021215

BIO-LOGIC ABAER CUB by Bio-Logic Systems Corp. — Product Code GWJ

K021215 is an FDA 510(k) premarket notification submitted by Bio-Logic Systems Corp. for the device "BIO-LOGIC ABAER CUB". The FDA issued a decision of Substantially Equivalent on May 15, 2002. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Bio-Logic Systems Corp. has at least 10 other 510(k) clearances on record.