TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4

TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 is an FDA 510(k)-cleared medical device (K932571) manufactured by Tomey Corporation USA. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 1995. Regulation: 8.