FDA 510(k), K190593, Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
FDA 510(k), K190593, Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
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510(K) Number: K190593
Device Name: Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
Manufacturer: iRhythm Technologies, Inc.
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 03/07/2019
Decision Date: 08/23/2019
Regulation Medical Specialty: Cardiovascular
Device Name: Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
Manufacturer: iRhythm Technologies, Inc.
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 03/07/2019
Decision Date: 08/23/2019
Regulation Medical Specialty: Cardiovascular
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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