510(k) K072254

VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM by Interacoustics A/S — Product Code GWN

K072254 is an FDA 510(k) premarket notification submitted by Interacoustics A/S for the device "VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM". The FDA issued a decision of Substantially Equivalent on February 5, 2008. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Interacoustics A/S has at least 10 other 510(k) clearances on record.