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FDA 510(k)

Zio AT® device (A100A1001)

K-Number: K240029 · 2024-10-21

ApplicantiRhythm Technologies, Inc.
Decision Date2024-10-21
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zio AT® device (A100A1001) is a medical device manufactured by iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2024-10-21 under approval number K240029. The device is classified under product code QYX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zio AT® device (A100A1001)?

Zio AT® device (A100A1001) is a medical device that received FDA 510(k) clearance on 2024-10-21. It is manufactured by iRhythm Technologies, Inc.. The 510(k) number is K240029.

When was Zio AT® device (A100A1001) approved by the FDA?

Zio AT® device (A100A1001) received FDA 510(k) clearance on 2024-10-21, under approval number K240029.

What company makes Zio AT® device (A100A1001)?

Zio AT® device (A100A1001) is manufactured by iRhythm Technologies, Inc..

What is the FDA product code for Zio AT® device (A100A1001)?

The FDA product code for Zio AT® device (A100A1001) is QYX.

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 K202527Zio ECG Utilization Software (ZEUS) System K202359Zio Monitor K213409ZEUS System (Zio Watch)

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Related Devices (Code: QYX)

K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. K162956NOWCARDIO SYSTEMContex International Technologies (Canada), Inc. K170565LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc. K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. K240653SmartCardia 7L Platform (MCT)Smartcardia SA K233584RhythmStar SystemRhythMedix, LLC

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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