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FDA 510(k), K173571, Element System with IBT Electrodes
FDA 510(k), K173571, Element System with IBT Electrodes
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510(K) Number: K173571
Device Name: Element System with IBT Electrodes
Manufacturer: Infinite Biomedical Technologies, LLC
Device Classification Name: electrode, cutaneous
Regulation Number: 882.1320
Classification Product Code: GXY
Date Received: 11/20/2017
Decision Date: 03/21/2018
Regulation Medical Specialty: Neurology
Device Name: Element System with IBT Electrodes
Manufacturer: Infinite Biomedical Technologies, LLC
Device Classification Name: electrode, cutaneous
Regulation Number: 882.1320
Classification Product Code: GXY
Date Received: 11/20/2017
Decision Date: 03/21/2018
Regulation Medical Specialty: Neurology
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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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