MODEL U-1000 WITH GESTATIONAL AGE CALCULATION

MODEL U-1000 WITH GESTATIONAL AGE CALCULATION is an FDA 510(k)-cleared medical device (K871385) manufactured by Fukuda Denshi USA, 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 25, 1987. Regulation: 8.