SCD(R) CONTROLLER

SCD(R) CONTROLLER is an FDA 510(k)-cleared medical device (K933259) manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 12, 1993. Regulation: 8.