TERUMO FETAL MONITOR # FHM-602

TERUMO FETAL MONITOR # FHM-602 is an FDA 510(k)-cleared medical device (K801747) manufactured by Terumo Medical 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 August 12, 1980. Regulation: 8.