MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045

MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 is an FDA 510(k)-cleared medical device (K050197) manufactured by Minitube of 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 October 5, 2006. Regulation: 8.