TOMEY PE-300 PORTABLE ERG

TOMEY PE-300 PORTABLE ERG is an FDA 510(k)-cleared medical device (K921815) manufactured by Tomey Corporation USA. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 14, 1992. Regulation: 8.