510(k) K842381

SLS 3500 LED VISUAL STIMULATOR by Nihon Kohden America, Inc. — Product Code GWE

K842381 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "SLS 3500 LED VISUAL STIMULATOR". The FDA issued a decision of Substantially Equivalent on November 9, 1984. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.