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FDA 510(k)

Nephros S100

K-Number: K153084 · 2016-04-08

ApplicantNephros, Inc.
Decision Date2016-04-08
Product CodeNHV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Nephros S100 is a medical device manufactured by Nephros, Inc.. It received FDA 510(k) clearance on 2016-04-08 under approval number K153084. The device is classified under product code NHV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nephros S100?

Nephros S100 is a medical device that received FDA 510(k) clearance on 2016-04-08. It is manufactured by Nephros, Inc.. The 510(k) number is K153084.

When was Nephros S100 approved by the FDA?

Nephros S100 received FDA 510(k) clearance on 2016-04-08, under approval number K153084.

What company makes Nephros S100?

Nephros S100 is manufactured by Nephros, Inc..

What is the FDA product code for Nephros S100?

The FDA product code for Nephros S100 is NHV.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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