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FDA 510(k)

GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS

K-Number: K933681 · 1994-09-07

ApplicantCobe Renal Care, Inc.
Decision Date1994-09-07
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Renal Care, Inc.. It received FDA 510(k) clearance on 1994-09-07 under 510(k) number K933681. 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 PRO 100, 500, 600 DIALYZERS?

GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS is a medical device that received FDA 510(k) clearance on 1994-09-07. The listed applicant is Cobe Renal Care, Inc.. The 510(k) number is K933681.

When did GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS receive FDA 510(k) clearance?

GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS received FDA 510(k) clearance on 1994-09-07, under 510(k) number K933681.

Who is the listed applicant for GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS?

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

What is the FDA product code for GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS?

The FDA product code for GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS is FJG.

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Other records listing Cobe Renal Care, 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.

K955497GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SETK955592COBE CENTRYSYSTEM 14 PES HEMODIALYZERSK955487GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERSK946279PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)K954003COBE HEMODYNAMIC RECIRCULATION MONITORK960474COBE CENTRYSYSTEM 600 HG HEMODIALYZERS

View all 14 devices →

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.

K933680GAMBRO LUNDIA PRO 200 DIALYZERCobe Renal Care, Inc.K920693DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9National Medical Care, Medical Products Div., Inc.K915504GAMBRO LUNDIA ALPHA HEMODIALYZERSC.G.H. Medical, 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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