510(k) K031352

BIO-LOGIC INSERT EARPHONES by Bio-Logic Systems Corp. — Product Code EWO

K031352 is an FDA 510(k) premarket notification submitted by Bio-Logic Systems Corp. for the device "BIO-LOGIC INSERT EARPHONES". The FDA issued a decision of Substantially Equivalent on July 16, 2003. 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.