FETALERT ADR FETAL MONITOR

FETALERT ADR FETAL MONITOR is an FDA 510(k)-cleared medical device (K871383) manufactured by Advanced Technology Laboratories, 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 May 31, 1987. Regulation: 8.