ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.

ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. is an FDA 510(k)-cleared medical device (K874861) manufactured by Acuson Computed Sonography. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 10, 1988. Regulation: 8.