DIGISCOPE OPHTHALMIC CAMERA

DIGISCOPE OPHTHALMIC CAMERA is an FDA 510(k)-cleared medical device (K990205) manufactured by Eye Tel Imaging, 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 March 25, 1999. Regulation: 8.