MODEL HEC-7 HEART EVALUATION COMPUTER

MODEL HEC-7 HEART EVALUATION COMPUTER is an FDA 510(k)-cleared medical device (K802952) manufactured by Kluwe Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 1981. Regulation: 8.