SITE-RITE VISION ULTRASOUND SYSTEM

SITE-RITE VISION ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K100402) manufactured by Bard Access Systems, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 4, 2010. Regulation: 8.