750 SD ULTRASOUND SCANNER(MODIFICATION)

750 SD ULTRASOUND SCANNER(MODIFICATION) is an FDA 510(k)-cleared medical device (K851901) manufactured by Ultrasonix, 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 October 22, 1985. Regulation: 8.