510(k) K101763

DIOPSYS NOVA VEP VISION TESTING SYSTEM by Diopsys, Inc. — Product Code GWE

K101763 is an FDA 510(k) premarket notification submitted by Diopsys, Inc. for the device "DIOPSYS NOVA VEP VISION TESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 9, 2011. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Diopsys, Inc. has at least 1 other 510(k) clearance on record.