TERASON USMART3400 ULTRASOUND SYSTEM

TERASON USMART3400 ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K140834) manufactured by Teratech 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 April 24, 2014. Regulation: 8.