RX-1 Rhythm Express Remote Cardiac Monitoring System

RX-1 Rhythm Express Remote Cardiac Monitoring System is an FDA 510(k)-cleared medical device (K200833) manufactured by VivaQuant, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 1, 2020. Regulation: 8.