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FDA 510(k)

GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY

K-Number: K892523 · 1989-05-11

ApplicantGambro, Inc.
Decision Date1989-05-11
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1989-05-11 under 510(k) number K892523. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY?

GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is Gambro, Inc.. The 510(k) number is K892523.

When did GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY receive FDA 510(k) clearance?

GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY received FDA 510(k) clearance on 1989-05-11, under 510(k) number K892523.

Who is the listed applicant for GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY?

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 ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY?

The FDA product code for GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY is FJI.

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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: FJI)

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.

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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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