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FDA 510(k)

GAMBRO LUNDIA ALPHA HEMODIALYZERS

K-Number: K915504 · 1992-03-06

ApplicantC.G.H. Medical, Inc.
Decision Date1992-03-06
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO LUNDIA ALPHA HEMODIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is C.G.H. Medical, Inc.. It received FDA 510(k) clearance on 1992-03-06 under 510(k) number K915504. The device is classified under product code FJG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO LUNDIA ALPHA HEMODIALYZERS?

GAMBRO LUNDIA ALPHA HEMODIALYZERS is a medical device that received FDA 510(k) clearance on 1992-03-06. The listed applicant is C.G.H. Medical, Inc.. The 510(k) number is K915504.

When did GAMBRO LUNDIA ALPHA HEMODIALYZERS receive FDA 510(k) clearance?

GAMBRO LUNDIA ALPHA HEMODIALYZERS received FDA 510(k) clearance on 1992-03-06, under 510(k) number K915504.

Who is the listed applicant for GAMBRO LUNDIA ALPHA HEMODIALYZERS?

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

What is the FDA product code for GAMBRO LUNDIA ALPHA HEMODIALYZERS?

The FDA product code for GAMBRO LUNDIA ALPHA HEMODIALYZERS is FJG.

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Other records listing C.G.H. Medical, 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.

K941708COBE CENTRYSYSTEM CS500 DIALYZERK933818GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTERK925522CENTRYSYSTEM 3 WITH CHARTS/BP OPTIONK920757FILTRAL HEMODIALYZERSK931720LUNDIA ALPHA 700 HEMODIALYZERK924437HEMOSPAL KIT B22 / MULTIFLOW 60 KIT

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Related Devices (Code: FJG)

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.

K933681GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSCobe Renal Care, Inc.K933680GAMBRO LUNDIA PRO 200 DIALYZERCobe Renal Care, Inc.K920693DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9National Medical Care, Medical Products Div., Inc.K901368HEMOSPAL KITS A1, A2D, AO, & A1DGambro-Hospal, Inc.K902203TENCKHOFF PERITONEAL DIALYSIS KITAkcess Medical Products, Inc.K862840GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6NGambro, 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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