AMICO DH-W35 OPHTHALMOSCOPE SERIES

AMICO DH-W35 OPHTHALMOSCOPE SERIES is an FDA 510(k)-cleared medical device (K131939) manufactured by Amico Diagnostic Incorporated. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 2014. Regulation: 8.