ULTRASOUND TRANSDUCER SHEATHS, STERILE

ULTRASOUND TRANSDUCER SHEATHS, STERILE is an FDA 510(k)-cleared medical device (K871609) manufactured by Amedic USA. 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 14, 1987. Regulation: 8.