FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US

FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US is an FDA 510(k)-cleared medical device (K121035) manufactured by Fujifilm Medical System U.S.A., Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 3, 2012. Regulation: 8.