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FDA 510(k), K181502, Zio AT ECG Monitoring System, ZEUS System
FDA 510(k), K181502, Zio AT ECG Monitoring System, ZEUS System
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$149.00 USD
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510(K) Number: K181502
Device Name: Zio AT ECG Monitoring System, ZEUS System
Manufacturer: iRhythm Technologies, Inc.
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 06/07/2018
Decision Date: 08/29/2018
Regulation Medical Specialty: Cardiovascular
Device Name: Zio AT ECG Monitoring System, ZEUS System
Manufacturer: iRhythm Technologies, Inc.
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 06/07/2018
Decision Date: 08/29/2018
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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