40 L HIGH FLOW INSUFFLATOR F108

40 L HIGH FLOW INSUFFLATOR F108 is an FDA 510(k)-cleared medical device (K030837) manufactured by W.O.M. World of Medicine AG. 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 February 4, 2004. Regulation: 8.