DOPPLEX ULTRASONIC DOPPLER SYSTEM

DOPPLEX ULTRASONIC DOPPLER SYSTEM is an FDA 510(k)-cleared medical device (K873989) manufactured by Ultramed, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 1, 1988. Regulation: 8.