
Ge Medical Syst. Information Technologies
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MAC 800 RESTING ECG ANALYSIS SYSTEM is an FDA 510(k)-cleared medical device (K090212) manufactured by Ge Medical Syst. Information Technologies. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 18, 2009. Regulation: 8.