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FDA 510(k)

Zio AT ECG Monitoring System, ZEUS System

K-Number: K181502 · 2018-08-29

ApplicantiRhythm Technologies, Inc.
Decision Date2018-08-29
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zio AT ECG Monitoring System, ZEUS System is a medical device manufactured by iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2018-08-29 under approval number K181502. 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 AT ECG Monitoring System, ZEUS System?

Zio AT ECG Monitoring System, ZEUS System is a medical device that received FDA 510(k) clearance on 2018-08-29. It is manufactured by iRhythm Technologies, Inc.. The 510(k) number is K181502.

When was Zio AT ECG Monitoring System, ZEUS System approved by the FDA?

Zio AT ECG Monitoring System, ZEUS System received FDA 510(k) clearance on 2018-08-29, under approval number K181502.

What company makes Zio AT ECG Monitoring System, ZEUS System?

Zio AT ECG Monitoring System, ZEUS System is manufactured by iRhythm Technologies, Inc..

What is the FDA product code for Zio AT ECG Monitoring System, ZEUS System?

The FDA product code for Zio AT ECG Monitoring System, ZEUS System is DQK.

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Related PubMed Literature

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Other Devices by iRhythm Technologies, Inc.

K163512Zio AT ECG Monitoring System K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring System K202527Zio ECG Utilization Software (ZEUS) System K202359Zio Monitor K213409ZEUS System (Zio Watch) K222389ZEUS System

View all 10 devices →

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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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