NXSTAGE SYSTEM ONE WITH NXVIEW

Dialyzer, High Permeability With Or Without Sealed Dialysate System

NXSTAGE MEDICAL, INC.

The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage System One With Nxview.

Pre-market Notification Details

Device IDK133547
510k NumberK133547
Device Name:NXSTAGE SYSTEM ONE WITH NXVIEW
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant NXSTAGE MEDICAL, INC. 350 MERRIMACK STREET Lawrence,  MA  01843
ContactMary Lou Stroumbos
CorrespondentMary Lou Stroumbos
NXSTAGE MEDICAL, INC. 350 MERRIMACK STREET Lawrence,  MA  01843
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-19
Decision Date2014-03-03
Summary:summary

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