FDA 510(k), K112314, NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
FDA 510(k), K112314, NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
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510(K) Number: K112314
Device Name: NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
Manufacturer: NEPHROS, INC.
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 08/11/2011
Decision Date: 04/27/2012
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
Manufacturer: NEPHROS, INC.
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 08/11/2011
Decision Date: 04/27/2012
Regulation Medical Specialty: Gastroenterology/Urology
- 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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