Nephros S100— 510(k) K153084

Substantially Equivalent

Nephros, Inc.

FDA 510(k) clearance K153084 for Nephros S100, Substantially Equivalent on 2016-04-08. 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: 2015-10-26
Decision date: 2016-04-08
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.