NXSTAGE EXPRESS FLUID WARMER

Monitor, Temperature, Dialysis

NXSTAGE MEDICAL, INC.

The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage Express Fluid Warmer.

Pre-market Notification Details

Device IDK140623
510k NumberK140623
Device Name:NXSTAGE EXPRESS FLUID WARMER
ClassificationMonitor, Temperature, Dialysis
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 CodeFLA  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-11
Decision Date2014-06-16
Summary:summary

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