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FDA 510(k)

GAMBRO WATER PURIFICATION MONITOR WRD

K-Number: K811678 · 1981-07-10

ApplicantGambro, Inc.
Decision Date1981-07-10
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO WATER PURIFICATION MONITOR WRD is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811678. 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 MONITOR WRD?

GAMBRO WATER PURIFICATION MONITOR WRD is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Gambro, Inc.. The 510(k) number is K811678.

When did GAMBRO WATER PURIFICATION MONITOR WRD receive FDA 510(k) clearance?

GAMBRO WATER PURIFICATION MONITOR WRD received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811678.

Who is the listed applicant for GAMBRO WATER PURIFICATION MONITOR WRD?

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

What is the FDA product code for GAMBRO WATER PURIFICATION MONITOR WRD?

The FDA product code for GAMBRO WATER PURIFICATION MONITOR WRD is FIP.

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Other records listing Gambro, 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.

K083158EXALIS, SOFTWARE VERSION 1.15K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35K032431PRISMA M60/M100 SETSK896758GAMBRO BICARBONATE MONITOR BCM 10-3K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSK902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

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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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