NEPHROS DSU-H, NEPHROS SSU-H— 510(k) K141731

Substantially Equivalent

Nephros, Inc.

FDA 510(k) clearance K141731 for NEPHROS DSU-H, NEPHROS SSU-H, Substantially Equivalent on 2014-10-24. Applicant: Nephros, Inc.. Device class: 2.

Clearance details

Applicant: Nephros, Inc.
Product code: Product code NHV
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2014-06-27
Decision date: 2014-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: River Edge, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.