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FDA 510(k)

NX STAGE WATER PURIFICATION SYSTEM

K-Number: K042089 · 2004-11-24

ApplicantNxstage Medical, Inc.
Decision Date2004-11-24
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NX STAGE WATER PURIFICATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2004-11-24 under 510(k) number K042089. 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 NX STAGE WATER PURIFICATION SYSTEM?

NX STAGE WATER PURIFICATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-24. The listed applicant is Nxstage Medical, Inc.. The 510(k) number is K042089.

When did NX STAGE WATER PURIFICATION SYSTEM receive FDA 510(k) clearance?

NX STAGE WATER PURIFICATION SYSTEM received FDA 510(k) clearance on 2004-11-24, under 510(k) number K042089.

Who is the listed applicant for NX STAGE WATER PURIFICATION SYSTEM?

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

What is the FDA product code for NX STAGE WATER PURIFICATION SYSTEM?

The FDA product code for NX STAGE WATER PURIFICATION SYSTEM is FIP.

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Other records listing Nxstage Medical, 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.

K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)K233213NxStage PureFlow SolutionK230632VersiHD with GuideMe softwareK183158NxStage Cartridge Express with SpeedswapK181991NxStage Connected Health SystemK171331NxStage System One

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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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