HIGH FLOW INSUFFLATION UNIT UHI-4

HIGH FLOW INSUFFLATION UNIT UHI-4 is an FDA 510(k)-cleared medical device (K110294) manufactured by Olympus Medical Systems Corporation. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 2011. Regulation: 8.