KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C

KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C is an FDA 510(k)-cleared medical device (K954780) manufactured by Kowa Optimed, 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 November 30, 1995. Regulation: 8.