MODEL 500E INFANT MONITORING SYSTEM

MODEL 500E INFANT MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K873791) manufactured by Ge Medical Systems Information Technologies. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 22, 1987. Regulation: 8.