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FDA 510(k), K163512, Zio AT ECG Monitoring System
FDA 510(k), K163512, Zio AT ECG Monitoring System
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510(K) Number: K163512
Device Name: Zio AT ECG Monitoring System
Manufacturer: IRHYTHM TECHNOLOGIES, INC.
Device Classification Name: Outpatient Cardiac Telemetry
Regulation Number: 870.1025
Classification Product Code: QYX
Date Received: 12/15/2016
Decision Date: 06/02/2017
Regulation Medical Specialty: Cardiovascular
Device Name: Zio AT ECG Monitoring System
Manufacturer: IRHYTHM TECHNOLOGIES, INC.
Device Classification Name: Outpatient Cardiac Telemetry
Regulation Number: 870.1025
Classification Product Code: QYX
Date Received: 12/15/2016
Decision Date: 06/02/2017
Regulation Medical Specialty: Cardiovascular
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- 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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