
Fujifilm Medical Systems U.S.A, Inc.
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FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR is an FDA 510(k)-cleared medical device (K162749) manufactured by Fujifilm Medical Systems U.S.A, 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 14, 2017. Regulation: 8.