510(k) K061791

FOCUS VNG/ENG TYPE 1068 by Gn Otometrics A/S — Product Code GWN

K061791 is an FDA 510(k) premarket notification submitted by Gn Otometrics A/S for the device "FOCUS VNG/ENG TYPE 1068". The FDA issued a decision of Substantially Equivalent on July 11, 2006. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Gn Otometrics A/S has at least 10 other 510(k) clearances on record.