MODEL 7340 ULTRASOUND SYSTEM

MODEL 7340 ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K081794) manufactured by Esaote, S.p.A.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 9, 2008. Regulation: 8.