MAC 2000 ECG ANALYSIS SYSTEM

MAC 2000 ECG ANALYSIS SYSTEM is an FDA 510(k)-cleared medical device (K133622) manufactured by Wipro 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 January 22, 2014. Regulation: 8.