ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6

ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 is an FDA 510(k)-cleared medical device (K092997) manufactured by Edan Instruments, 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 November 9, 2009. Regulation: 8.