510(k) K932571

TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 by Tomey Corporation USA — Product Code GWE

K932571 is an FDA 510(k) premarket notification submitted by Tomey Corporation USA for the device "TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4". The FDA issued a decision of Substantially Equivalent on August 31, 1995. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Tomey Corporation USA has at least 8 other 510(k) clearances on record.