SITE-RITE 3 ULTRASOUND SYSTEM

SITE-RITE 3 ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K993624) manufactured by Dymax Corp. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 9, 1999. Regulation: 8.