BIOSYS FETAL MONITOR, MODEL IFM-500

BIOSYS FETAL MONITOR, MODEL IFM-500 is an FDA 510(k)-cleared medical device (K994008) manufactured by Biosys Co. , Ltd.. 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 September 28, 2000. Regulation: 8.