510(k) K031009

MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM by Bio-Logic Systems Corp. — Product Code GWJ

K031009 is an FDA 510(k) premarket notification submitted by Bio-Logic Systems Corp. for the device "MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM". The FDA issued a decision of Substantially Equivalent on April 28, 2003. 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.