THE TELESCAN C.A.R.E. SYSTEM

THE TELESCAN C.A.R.E. SYSTEM is an FDA 510(k)-cleared medical device (K871587) manufactured by Telescan Medical Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 1987. Regulation: 8.