510(k) K193303

Tinnitus Sound Generator Module by GN Hearing A/S — Product Code KLW

K193303 is an FDA 510(k) premarket notification submitted by GN Hearing A/S for the device "Tinnitus Sound Generator Module". The FDA issued a decision of Substantially Equivalent on February 20, 2020. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400. GN Hearing A/S has at least 4 other 510(k) clearances on record.