CARDI-O-LIFE MODEL 8823

CARDI-O-LIFE MODEL 8823 is an FDA 510(k)-cleared medical device (K821090) manufactured by Amertek. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 7, 1982. Regulation: 8.