PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE

PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE is an FDA 510(k)-cleared medical device (K810750) 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 March 26, 1981. Regulation: 8.