FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM

FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM is an FDA 510(k)-cleared medical device (K040048) 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 June 6, 2004. Regulation: 8.