
Ge Medical Systems Information Technologies
Free shipping on orders over $99 · 30-day returns
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM is an FDA 510(k)-cleared medical device (K033492) manufactured by Ge Medical Systems 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 November 23, 2003. Regulation: 8.