MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK

MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK is an FDA 510(k)-cleared medical device (K900271) manufactured by Digisonics, 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 April 18, 1990. Regulation: 8.