WELCH ALLYN OPHTHALMOSCOPE

WELCH ALLYN OPHTHALMOSCOPE is an FDA 510(k)-cleared medical device (K950461) 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 April 3, 1995. Regulation: 8.