MAC 7 - Resting ECG Analysis System

MAC 7 - Resting ECG Analysis System is an FDA 510(k)-cleared medical device (K203786) manufactured by Ge Medical Systems Information Technologies, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 2021. Regulation: 8.