MODEL 515 NEO-TRAK NEONATAL MONITOR

MODEL 515 NEO-TRAK NEONATAL MONITOR is an FDA 510(k)-cleared medical device (K823904) 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 May 24, 1983. Regulation: 8.