SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR

SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR is an FDA 510(k)-cleared medical device (K080087) 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 March 10, 2008. Regulation: 8.