Cleared Special

NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER

K110285 · Nephros, Inc. · Gastroenterology & Urology
Jul 2011
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K110285 is an FDA 510(k) clearance for the NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER, a Subsystem, Water Purification (Class II — Special Controls, product code FIP), submitted by Nephros, Inc. (River Edge, US). The FDA issued a Cleared decision on July 14, 2011, 164 days after receiving the submission on January 31, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5665.

Submission Details

510(k) Number K110285 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2011
Decision Date July 14, 2011
Days to Decision 164 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FIP — Subsystem, Water Purification
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5665

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