Zio AT ECG Monitoring System, ZEUS System

Zio AT ECG Monitoring System, ZEUS System is an FDA 510(k)-cleared medical device (K181502) manufactured by iRhythm Technologies, 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 August 28, 2018. Regulation: 8.