DIGITAL FUNDUS CAMERA, MODEL CF-60DSI

DIGITAL FUNDUS CAMERA, MODEL CF-60DSI is an FDA 510(k)-cleared medical device (K041546) manufactured by Canon, 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 June 22, 2004. Regulation: 8.