DATASON DB ULTRASOUND IMAGING SYSTEM

DATASON DB ULTRASOUND IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K810305) manufactured by General Electric Co.. 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 March 12, 1981. Regulation: 8.