EndoPur Filter

Subsystem, Water Purification

Nephros Inc.

The following data is part of a premarket notification filed by Nephros Inc. with the FDA for Endopur Filter.

Pre-market Notification Details

Device IDK161304
510k NumberK161304
Device Name:EndoPur Filter
ClassificationSubsystem, Water Purification
Applicant Nephros Inc. 41 Grand Ave River Edge,  NJ  07661
ContactHollie Johnson
CorrespondentHollie Johnson
Nephros Inc. 41 Grand Ave River Edge,  NJ  07661
Product CodeFIP  
CFR Regulation Number876.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-10
Decision Date2017-03-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
02086827700062 K161304 000
10896241002685 K161304 000
10868277000447 K161304 000
10868277000454 K161304 000
10868277000416 K161304 000
10868277000423 K161304 000
20868277000437 K161304 000
02086827700048 K161304 000
01086827700056 K161304 000
10866318000388 K161304 000

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