TELETRACE TELEPHONE EKG SYSTEM

TELETRACE TELEPHONE EKG SYSTEM is an FDA 510(k)-cleared medical device (K811512) 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 June 29, 1981. Regulation: 8.