FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS

FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS is an FDA 510(k)-cleared medical device (K100797) manufactured by Edan Instruments, Inc.. 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 November 9, 2010. Regulation: 8.