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FDA 510(k)

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

K-Number: K093608 · 2010-07-29

ApplicantGambro Renal Products, Inc.
Decision Date2010-07-29
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H is the device name listed in this FDA 510(k) record. The listed applicant is Gambro Renal Products, Inc.. It received FDA 510(k) clearance on 2010-07-29 under 510(k) number K093608. 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 WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H?

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H is a medical device that received FDA 510(k) clearance on 2010-07-29. The listed applicant is Gambro Renal Products, Inc.. The 510(k) number is K093608.

When did GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H receive FDA 510(k) clearance?

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H received FDA 510(k) clearance on 2010-07-29, under 510(k) number K093608.

Who is the listed applicant for GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H?

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

What is the FDA product code for GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H?

The FDA product code for GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H is FIP.

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Other records listing Gambro Renal Products, 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.

K130039REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZERK113313MOLECULAR ADSORBENT RECIRCULATING(MARS)K110823PRISMAFLEXK103832PHOENIX HEMODIALYSIS DELIVERY SYSTEMK100451GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132K100364GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

View all 11 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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