
Fujifilm Medical System U.S.A., Inc.
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EPX-4440HD and EPX-4400HD with FICE is an FDA 510(k)-cleared medical device (K150221) manufactured by Fujifilm Medical System 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 September 30, 2015. Regulation: 8.