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FDA 510(k), K183311, Ivenix Infusion System (IIS)
FDA 510(k), K183311, Ivenix Infusion System (IIS)
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510(K) Number: K183311
Device Name: Ivenix Infusion System (IIS)
Manufacturer: Ivenix, Inc.
Device Classification Name: pump, infusion
Regulation Number: 880.5725
Classification Product Code: FRN
Date Received: 11/29/2018
Decision Date: 06/07/2019
Regulation Medical Specialty: General Hospital
Device Name: Ivenix Infusion System (IIS)
Manufacturer: Ivenix, Inc.
Device Classification Name: pump, infusion
Regulation Number: 880.5725
Classification Product Code: FRN
Date Received: 11/29/2018
Decision Date: 06/07/2019
Regulation Medical Specialty: General Hospital
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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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