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FDA 510(k)

Zio XT ECG Monitoring System, Zio AT ECG Monitoring System

K-Number: K190593 · 2019-08-23

ApplicantiRhythm Technologies, Inc.
Decision Date2019-08-23
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zio XT ECG Monitoring System, Zio AT ECG Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2019-08-23 under 510(k) number K190593. 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 XT ECG Monitoring System, Zio AT ECG Monitoring System?

Zio XT ECG Monitoring System, Zio AT ECG Monitoring System is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is iRhythm Technologies, Inc.. The 510(k) number is K190593.

When did Zio XT ECG Monitoring System, Zio AT ECG Monitoring System receive FDA 510(k) clearance?

Zio XT ECG Monitoring System, Zio AT ECG Monitoring System received FDA 510(k) clearance on 2019-08-23, under 510(k) number K190593.

Who is the listed applicant for Zio XT ECG Monitoring System, Zio AT ECG Monitoring System?

The FDA 510(k) record lists iRhythm Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07205367Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA IICOMPLETED

Other records listing iRhythm Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252859ZEUS Platform (FG0501US)K243650Zio® monitor (DFG0001)K240177Zio AT® device (A100A1001)K240029Zio AT® device (A100A1001)K222389ZEUS SystemK213409ZEUS System (Zio Watch)

View all 11 devices →

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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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