510(k) K081234

GN OTOMETRICS INSERT EARPHONES by Gn Otometrics — Product Code EWO

K081234 is an FDA 510(k) premarket notification submitted by Gn Otometrics for the device "GN OTOMETRICS INSERT EARPHONES". The FDA issued a decision of Substantially Equivalent on July 14, 2008. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Gn Otometrics has at least 10 other 510(k) clearances on record.