LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE

LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE is an FDA 510(k)-cleared medical device (K943732) manufactured by Graphic Controls Corp.. 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 19, 1994. Regulation: 8.