
iRhythm Technologies, Inc.
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ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM is an FDA 510(k)-cleared medical device (K091075) 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 July 20, 2009. Regulation: 8.