MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE

MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE is an FDA 510(k)-cleared medical device (K904745) 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 January 28, 1991. Regulation: 8.