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FDA 510(k)

Zio ECG Utilization Software (ZEUS) System

K-Number: K202527 · 2021-05-21

ApplicantiRhythm Technologies, Inc.
Decision Date2021-05-21
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zio ECG Utilization Software (ZEUS) System is a medical device manufactured by iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2021-05-21 under approval number K202527. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zio ECG Utilization Software (ZEUS) System?

Zio ECG Utilization Software (ZEUS) System is a medical device that received FDA 510(k) clearance on 2021-05-21. It is manufactured by iRhythm Technologies, Inc.. The 510(k) number is K202527.

When was Zio ECG Utilization Software (ZEUS) System approved by the FDA?

Zio ECG Utilization Software (ZEUS) System received FDA 510(k) clearance on 2021-05-21, under approval number K202527.

What company makes Zio ECG Utilization Software (ZEUS) System?

Zio ECG Utilization Software (ZEUS) System is manufactured by iRhythm Technologies, Inc..

What is the FDA product code for Zio ECG Utilization Software (ZEUS) System?

The FDA product code for Zio ECG Utilization Software (ZEUS) System is DQK.

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Other Devices by iRhythm Technologies, Inc.

K163512Zio AT ECG Monitoring System K181502Zio AT ECG Monitoring System, ZEUS System K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring System K202359Zio Monitor K213409ZEUS System (Zio Watch) K222389ZEUS System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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