APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300

APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300 is an FDA 510(k)-cleared medical device (K873214) manufactured by General Electric Co.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 31, 1988. Regulation: 8.