TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA

TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA is an FDA 510(k)-cleared medical device (K041367) manufactured by Topcon Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 2004. Regulation: 8.