TRC-NW8 NON-MYDRIATIC RETINAL CAMERA

TRC-NW8 NON-MYDRIATIC RETINAL CAMERA is an FDA 510(k)-cleared medical device (K130289) 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 May 9, 2013. Regulation: 8.