OPERAND* ULTRASOUND TRANSMISSION GEL

OPERAND* ULTRASOUND TRANSMISSION GEL is an FDA 510(k)-cleared medical device (K951695) manufactured by Redi Products, 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 May 11, 1995. Regulation: 8.