CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR

CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR is an FDA 510(k)-cleared medical device (K082369) 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 6, 2008. Regulation: 8.