MONOCULAR DIRECT OPHTHALMOSCOPE

MONOCULAR DIRECT OPHTHALMOSCOPE is an FDA 510(k)-cleared medical device (K844971) manufactured by Nidek, 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 February 14, 1985. Regulation: 8.