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FDA 510(k)

FRESENIUS HEMOFLOW, VARIOUS MODELS

K-Number: K926005 · 1994-08-23

ApplicantFresenius USA, Inc.
Decision Date1994-08-23
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS HEMOFLOW, VARIOUS MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius USA, Inc.. It received FDA 510(k) clearance on 1994-08-23 under 510(k) number K926005. 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 FRESENIUS HEMOFLOW, VARIOUS MODELS?

FRESENIUS HEMOFLOW, VARIOUS MODELS is a medical device that received FDA 510(k) clearance on 1994-08-23. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K926005.

When did FRESENIUS HEMOFLOW, VARIOUS MODELS receive FDA 510(k) clearance?

FRESENIUS HEMOFLOW, VARIOUS MODELS received FDA 510(k) clearance on 1994-08-23, under 510(k) number K926005.

Who is the listed applicant for FRESENIUS HEMOFLOW, VARIOUS MODELS?

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

What is the FDA product code for FRESENIUS HEMOFLOW, VARIOUS MODELS?

The FDA product code for FRESENIUS HEMOFLOW, VARIOUS MODELS is FJI.

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Other records listing Fresenius USA, 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.

K992275FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TSK970700FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUXK974584FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TSK973378C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61K9614652008H ON LINE CLEARANCE MONITORK961706P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR

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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.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

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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