CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512

CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512 is an FDA 510(k)-cleared medical device (K900246) manufactured by Ppg Industries, 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 July 2, 1990. Regulation: 8.