SURECALL EMG LABOR MONITOR

SURECALL EMG LABOR MONITOR is an FDA 510(k)-cleared medical device (K090145) manufactured by Reproductive Research Technologies, LP. 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 January 24, 2011. Regulation: 8.