SHEATHESISO ULTRASOUND TRANSDUCER COVER

SHEATHESISO ULTRASOUND TRANSDUCER COVER is an FDA 510(k)-cleared medical device (K091828) manufactured by Sheathing Technologies, 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 September 27, 2009. Regulation: 8.