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FDA 510(k)

NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER

K-Number: K090885 · 2009-06-29

ApplicantNephros, Inc.
Decision Date2009-06-29
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER is the device name listed in this FDA 510(k) record. The listed applicant is Nephros, Inc.. It received FDA 510(k) clearance on 2009-06-29 under 510(k) number K090885. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER?

NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER is a medical device that received FDA 510(k) clearance on 2009-06-29. The listed applicant is Nephros, Inc.. The 510(k) number is K090885.

When did NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER receive FDA 510(k) clearance?

NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER received FDA 510(k) clearance on 2009-06-29, under 510(k) number K090885.

Who is the listed applicant for NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER?

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, INC., DSU DUAL STAGE ULTRAFILTER?

The FDA product code for NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER is FIP.

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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.

K161304EndoPur FilterK161467HydraGuard 10 UltraFilterK153084Nephros S100K112314NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTERK110285NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTERK050603OLPUR DIALYZER, MODEL HD 190

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Related Devices (Code: FIP)

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.

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, Inc.

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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