FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5

FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 is an FDA 510(k)-cleared medical device (K042043) manufactured by Fujinon, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 23, 2004. Regulation: 8.