FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM)

FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) is an FDA 510(k)-cleared medical device (K871944) manufactured by Futurecare Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 1987. Regulation: 8.