BINOCULAR INDIRECT OPHTHALMOSCOPE

BINOCULAR INDIRECT OPHTHALMOSCOPE is an FDA 510(k)-cleared medical device (K843304) manufactured by Mentor O & O, 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 November 20, 1984. Regulation: 8.