CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS

CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS is an FDA 510(k)-cleared medical device (K963065) manufactured by Shantou Institute of Ultrasonic Instuments. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 1997. Regulation: 8.