#505 PORT. VITAL FUNCTIONS NEONATAL MON

#505 PORT. VITAL FUNCTIONS NEONATAL MON is an FDA 510(k)-cleared medical device (K820416) 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 March 3, 1982. Regulation: 8.