COROMETRICS FETAL MOVEMENT DETECTION KIT

COROMETRICS FETAL MOVEMENT DETECTION KIT is an FDA 510(k)-cleared medical device (K955559) 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 March 4, 1996. Regulation: 8.