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FDA 510(k)

HydraGuard 10 UltraFilter

K-Number: K161467 · 2016-12-22

ApplicantNephros, Inc.
Decision Date2016-12-22
Product CodeNHV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HydraGuard 10 UltraFilter is a medical device manufactured by Nephros, Inc.. It received FDA 510(k) clearance on 2016-12-22 under approval number K161467. 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 HydraGuard 10 UltraFilter?

HydraGuard 10 UltraFilter is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Nephros, Inc.. The 510(k) number is K161467.

When was HydraGuard 10 UltraFilter approved by the FDA?

HydraGuard 10 UltraFilter received FDA 510(k) clearance on 2016-12-22, under approval number K161467.

What company makes HydraGuard 10 UltraFilter?

HydraGuard 10 UltraFilter is manufactured by Nephros, Inc..

What is the FDA product code for HydraGuard 10 UltraFilter?

The FDA product code for HydraGuard 10 UltraFilter is NHV.

Other Devices by Nephros, Inc.

K153084Nephros S100 K161304EndoPur Filter

Related Devices (Code: 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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