CERNER FETALINK+(VERSION1.0)

CERNER FETALINK+(VERSION1.0) is an FDA 510(k)-cleared medical device (K121758) manufactured by Cerner 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 October 8, 2012. Regulation: 8.