
General Electric Medical Systems Information Techn
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MAC-LAB/CARDIOLAB EP/COMBOLAB is an FDA 510(k)-cleared medical device (K021366) manufactured by General Electric Medical Systems Information Techn. 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, 2002. Regulation: 8.