510(k) K221168

Tinnitogram Signal Generator by Goldenear Company, Inc. — Product Code KLW

K221168 is an FDA 510(k) premarket notification submitted by Goldenear Company, Inc. for the device "Tinnitogram Signal Generator". The FDA issued a decision of Substantially Equivalent on February 1, 2023. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400.