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FDA 510(k)

FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

K-Number: K002761 · 2000-12-04

ApplicantFresenius Medical Care North America
Decision Date2000-12-04
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care North America. It received FDA 510(k) clearance on 2000-12-04 under 510(k) number K002761. 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 FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS?

FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS is a medical device that received FDA 510(k) clearance on 2000-12-04. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K002761.

When did FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS receive FDA 510(k) clearance?

FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS received FDA 510(k) clearance on 2000-12-04, under 510(k) number K002761.

Who is the listed applicant for FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS?

The FDA 510(k) record lists Fresenius Medical Care North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS?

The FDA product code for FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS is FJI.

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Other records listing Fresenius Medical Care North America as applicant

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K252181AquaAK162488Optiflux dialyzerK131611FRESENIUS DRY ACID DISSOLUTION UNITSK1240352008K@HOME HEMODIALYSIS MACHINEK121341FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEMK121599CRIT-LINE CLIP (CLIC)

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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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K991908IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERSIdemsa

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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