NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM

NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM is an FDA 510(k)-cleared medical device (K980246) manufactured by Canon USA, Inc.. 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 5, 1998. Regulation: 8.