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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 a medical device manufactured by iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2019-08-23 under approval 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. It is manufactured by iRhythm Technologies, Inc.. The 510(k) number is K190593.

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

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

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

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

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

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING

Related PubMed Literature

PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022)

Other Devices by iRhythm Technologies, Inc.

K163512Zio AT ECG Monitoring System K181502Zio AT ECG Monitoring System, ZEUS 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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