MINDCHILD MERIDIAN FETAL HEART RATE MONITOR

MINDCHILD MERIDIAN FETAL HEART RATE MONITOR is an FDA 510(k)-cleared medical device (K120018) manufactured by Mindchild Medical. 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 September 18, 2012. Regulation: 8.