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FDA 510(k)

GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM

K-Number: K981085 · 1998-05-18

ApplicantGambro Healthcare
Decision Date1998-05-18
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gambro Healthcare. It received FDA 510(k) clearance on 1998-05-18 under 510(k) number K981085. 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 GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM?

GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-18. The listed applicant is Gambro Healthcare. The 510(k) number is K981085.

When did GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM receive FDA 510(k) clearance?

GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM received FDA 510(k) clearance on 1998-05-18, under 510(k) number K981085.

Who is the listed applicant for GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM?

The FDA 510(k) record lists Gambro Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM?

The FDA product code for GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM is FIP.

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Other records listing Gambro Healthcare 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.

K994390GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTERK990039GAMBRO DQM 200K982413COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERSK982414GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERSK980386HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)K982760COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET

View all 13 devices →

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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