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FDA 510(k)

DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS

K-Number: K082400 · 2009-02-03

ApplicantCulligan Soft Water Service Co.
Decision Date2009-02-03
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Culligan Soft Water Service Co.. It received FDA 510(k) clearance on 2009-02-03 under 510(k) number K082400. 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 DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS?

DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 2009-02-03. The listed applicant is Culligan Soft Water Service Co.. The 510(k) number is K082400.

When did DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS receive FDA 510(k) clearance?

DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS received FDA 510(k) clearance on 2009-02-03, under 510(k) number K082400.

Who is the listed applicant for DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS?

The FDA 510(k) record lists Culligan Soft Water Service Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS?

The FDA product code for DEIONIZER AND CARBON EXCHANGE SERVICE FOR 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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