FDA 510(k)

MÁQUINA DE DIÁLISIS AK 98, FILTRADOR ULTRAPERFUSION U9000, ACCESORIO DE CÁMARA DE EXPANSIÓN C705

N.º K: K201809 · 2021-03-10

SolicitanteBaxter Healthcare Corportation

Fecha de decisión2021-03-10

Código de productoKDI

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corportation. It received FDA 510(k) clearance on 2021-03-10 under 510(k) number K201809. 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 AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is a medical device that received FDA 510(k) clearance on 2021-03-10. The listed applicant is Baxter Healthcare Corportation. The 510(k) number is K201809.

When did AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory receive FDA 510(k) clearance?

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory received FDA 510(k) clearance on 2021-03-10, under 510(k) number K201809.

Who is the listed applicant for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

The FDA 510(k) record lists Baxter Healthcare Corportation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

The FDA product code for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory is KDI.

Ensayos clínicos relacionados

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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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