MAC 5000 ECG ANALYSIS SYSTEM

MAC 5000 ECG ANALYSIS SYSTEM is an FDA 510(k)-cleared medical device (K014108) 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 January 9, 2002. Regulation: 8.