Model BT-220L and BT-220C

Model BT-220L and BT-220C is an FDA 510(k)-cleared medical device (K142799) manufactured by Bistos Co., Ltd.. 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 July 8, 2015. Regulation: 8.