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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 the device name listed in this FDA 510(k) record. The listed applicant is Nephros, Inc.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) 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. The listed applicant is Nephros, Inc.. The 510(k) number is K153084.

When did Nephros S100 receive FDA 510(k) clearance?

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

Who is the listed applicant for Nephros S100?

The FDA 510(k) record lists Nephros, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nephros S100?

The FDA product code for Nephros S100 is NHV.

Other records listing Nephros, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NHV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222727i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)I3 Membrane GmbHK191563FILTRAY 2G Disposable Water FiltersAqua-ToolsK182164Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower WandEcolab, Inc.K173164Ecolab POU Water FilterEcolab, Inc.K163609Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)Pall International SarlK161467HydraGuard 10 UltraFilterNephros, Inc.

Official Source

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

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