OPHTHALMOSCOPE, BINOCULAR, INDIRECT

OPHTHALMOSCOPE, BINOCULAR, INDIRECT is an FDA 510(k)-cleared medical device (K772214) manufactured by Varian Assoc., 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 December 12, 1977. Regulation: 8.