MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST

MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST is an FDA 510(k)-cleared medical device (K914974) 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 December 18, 1991. Regulation: 8.