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FDA 510(k)

FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS

K-Number: K991495 · 2000-08-28

ApplicantFluid Process Systems, Inc.
Decision Date2000-08-28
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Fluid Process Systems, Inc.. It received FDA 510(k) clearance on 2000-08-28 under 510(k) number K991495. 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 FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS?

FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 2000-08-28. The listed applicant is Fluid Process Systems, Inc.. The 510(k) number is K991495.

When did FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS receive FDA 510(k) clearance?

FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS received FDA 510(k) clearance on 2000-08-28, under 510(k) number K991495.

Who is the listed applicant for FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS?

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

What is the FDA product code for FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS?

The FDA product code for FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS is FIP.

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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

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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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