
GE Healthcare
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MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM is an FDA 510(k)-cleared medical device (K061741) manufactured by GE Healthcare. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 2006. Regulation: 8.