VITALERT 3000 MONITORING SYSTEM

VITALERT 3000 MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K913995) manufactured by Draeger Medical, Inc.. 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 2, 1992. Regulation: 8.