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FDA 510(k)

2008H ON LINE CLEARANCE MONITOR

K-Number: K961465 · 1997-07-03

ApplicantFresenius USA, Inc.
Decision Date1997-07-03
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

2008H ON LINE CLEARANCE MONITOR 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 1997-07-03 under 510(k) number K961465. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2008H ON LINE CLEARANCE MONITOR?

2008H ON LINE CLEARANCE MONITOR is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K961465.

When did 2008H ON LINE CLEARANCE MONITOR receive FDA 510(k) clearance?

2008H ON LINE CLEARANCE MONITOR received FDA 510(k) clearance on 1997-07-03, under 510(k) number K961465.

Who is the listed applicant for 2008H ON LINE CLEARANCE MONITOR?

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 2008H ON LINE CLEARANCE MONITOR?

The FDA product code for 2008H ON LINE CLEARANCE MONITOR is KDI.

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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 61K961706P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATORK955762PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

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Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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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