ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN

ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN is an FDA 510(k)-cleared medical device (K853702) manufactured by Johnson & Johnson Professionals, 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 February 12, 1986. Regulation: 8.