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FDA 510(k)

WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K-Number: K042797 · 2005-03-09

ApplicantGambro Renal Products
Decision Date2005-03-09
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Gambro Renal Products. It received FDA 510(k) clearance on 2005-03-09 under 510(k) number K042797. 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 WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS?

WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 2005-03-09. The listed applicant is Gambro Renal Products. The 510(k) number is K042797.

When did WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS receive FDA 510(k) clearance?

WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS received FDA 510(k) clearance on 2005-03-09, under 510(k) number K042797.

Who is the listed applicant for WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS?

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

What is the FDA product code for WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS?

The FDA product code for WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS is FIP.

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Other records listing Gambro Renal Products 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.

K120333PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPYK072908PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYK070414GAMBRO CARTRIDGE BLOOD SETSK063290GAMBRO QUICKSET BLOODLINESK062090PRISMA SYSTEM R03.10AK060195GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE

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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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