AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA

AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA is an FDA 510(k)-cleared medical device (K851262) 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 29, 1985. Regulation: 8.