AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP

AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP is an FDA 510(k)-cleared medical device (K851263) manufactured by American Medical Optics. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 1985. Regulation: 8.