MODEL 2120IS SERIES MATERNAL/FETAL MONITOR

MODEL 2120IS SERIES MATERNAL/FETAL MONITOR is an FDA 510(k)-cleared medical device (K021135) 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 May 8, 2002. Regulation: 8.