FDA 510(k)

Sistema de Hemodiálisis 5008X

N.º K: K231534 · 2024-02-02

Fecha de decisión2024-02-02

Código de productoKDI

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

5008X Hemodialysis System 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 2024-02-02 under 510(k) number K231534. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 5008X Hemodialysis System?

5008X Hemodialysis System is a medical device that received FDA 510(k) clearance on 2024-02-02. The listed applicant is Fresenius Medical Care. The 510(k) number is K231534.

When did 5008X Hemodialysis System receive FDA 510(k) clearance?

5008X Hemodialysis System received FDA 510(k) clearance on 2024-02-02, under 510(k) number K231534.

Who is the listed applicant for 5008X Hemodialysis System?

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 5008X Hemodialysis System?

The FDA product code for 5008X Hemodialysis System is KDI.

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Dispositivos relacionados (Código: KDI)

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC K260533ELISIO™-HNipro Medical Corporation K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

Fuente oficial

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