NON-PYROGENIC ULTRASOUND TRANSDUCER COVER

NON-PYROGENIC ULTRASOUND TRANSDUCER COVER is an FDA 510(k)-cleared medical device (K131528) manufactured by CIVCO Medical Instruments Co., Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 10, 2013. Regulation: 8.