KITECKO ULTRASOUND STANDOFF PAD

KITECKO ULTRASOUND STANDOFF PAD is an FDA 510(k)-cleared medical device (K851982) manufactured by 3M Company. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 1985. Regulation: 8.