SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4

SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4 is an FDA 510(k)-cleared medical device (K890963) manufactured by Esaote Biomedica Elettronica. 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 18, 1989. Regulation: 8.