FETAL MONITOR, MODELS BT-300 AND BT-200

FETAL MONITOR, MODELS BT-300 AND BT-200 is an FDA 510(k)-cleared medical device (K052190) 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 October 3, 2005. Regulation: 8.