ACUSON L558 TRANSDUCER

ACUSON L558 TRANSDUCER is an FDA 510(k)-cleared medical device (K861579) 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 July 29, 1986. Regulation: 8.