FDA 510(k)

Máquina de Diálise AK 98 (955607)

Número K: K250508 · 2025-08-01

Data da decisão2025-08-01

Código do produtoKDI

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

AK 98 Dialysis Machine (955607) is the device name listed in this FDA 510(k) record. The listed applicant is Vantive US Healthcare, LLC. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K250508. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AK 98 Dialysis Machine (955607)?

AK 98 Dialysis Machine (955607) is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is Vantive US Healthcare, LLC. The 510(k) number is K250508.

When did AK 98 Dialysis Machine (955607) receive FDA 510(k) clearance?

AK 98 Dialysis Machine (955607) received FDA 510(k) clearance on 2025-08-01, under 510(k) number K250508.

Who is the listed applicant for AK 98 Dialysis Machine (955607)?

The FDA 510(k) record lists Vantive US Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AK 98 Dialysis Machine (955607)?

The FDA product code for AK 98 Dialysis Machine (955607) is KDI.

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Fonte oficial

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