COROMETRICS 115 FETAL MONITOR

COROMETRICS 115 FETAL MONITOR is an FDA 510(k)-cleared medical device (K843385) manufactured by Ge Medical Systems Information Technologies. 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 November 28, 1984. Regulation: 8.