510(k) K030907

STACKED ABR FOR NAVIGATOR PRO by Bio-Logic Systems Corp. — Product Code GWJ

K030907 is an FDA 510(k) premarket notification submitted by Bio-Logic Systems Corp. for the device "STACKED ABR FOR NAVIGATOR PRO". The FDA issued a decision of Substantially Equivalent on May 9, 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.