MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE

MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE is an FDA 510(k)-cleared medical device (K930023) manufactured by Welch Allyn, 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 June 20, 1993. Regulation: 8.