MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR

MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR is an FDA 510(k)-cleared medical device (K915769) 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 January 29, 1992. Regulation: 8.