CARD GUARD MODEL CG-8000

CARD GUARD MODEL CG-8000 is an FDA 510(k)-cleared medical device (K926515) manufactured by Card Guard Scientific Survival , Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 1994. Regulation: 8.