MODEL 9444 TELETRACE II ECG MONITORING SYSTEM

MODEL 9444 TELETRACE II ECG MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K903960) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 8, 1990. Regulation: 8.