OLYMPUS HIGH FLOW INSUFFLATION UNIT

OLYMPUS HIGH FLOW INSUFFLATION UNIT is an FDA 510(k)-cleared medical device (K953162) manufactured by Olympus America, Inc.. 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 December 18, 1995. Regulation: 8.