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FDA 510(k)

FRESENIUS 2008K

K-Number: K994267 · 2000-03-16

ApplicantFresenius Medical Care
Decision Date2000-03-16
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS 2008K is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care. It received FDA 510(k) clearance on 2000-03-16 under 510(k) number K994267. 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 FRESENIUS 2008K?

FRESENIUS 2008K is a medical device that received FDA 510(k) clearance on 2000-03-16. The listed applicant is Fresenius Medical Care. The 510(k) number is K994267.

When did FRESENIUS 2008K receive FDA 510(k) clearance?

FRESENIUS 2008K received FDA 510(k) clearance on 2000-03-16, under 510(k) number K994267.

Who is the listed applicant for FRESENIUS 2008K?

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

What is the FDA product code for FRESENIUS 2008K?

The FDA product code for FRESENIUS 2008K is KDI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Fresenius Medical Care 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.

K2315345008X Hemodialysis SystemK111639FRESENIUS 2008T HEMODIALYSIS MACHINEK030497FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIESK023162FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETSK022536\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR

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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