510(k) K121512

SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM by Bio-Logic Systems Corp. — Product Code EWO

K121512 is an FDA 510(k) premarket notification submitted by Bio-Logic Systems Corp. for the device "SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on July 26, 2012. 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.