FDA 510(k)

AquaBplus; AquaB LITE

Número K: K232953 · 2024-06-13

RequerenteFresenius Medical Care Renal Therapies Group, LLC

Data da decisão2024-06-13

Código do produtoFIP

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

AquaBplus; AquaB LITE is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2024-06-13 under 510(k) number K232953. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AquaBplus; AquaB LITE?

AquaBplus; AquaB LITE is a medical device that received FDA 510(k) clearance on 2024-06-13. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K232953.

When did AquaBplus; AquaB LITE receive FDA 510(k) clearance?

AquaBplus; AquaB LITE received FDA 510(k) clearance on 2024-06-13, under 510(k) number K232953.

Who is the listed applicant for AquaBplus; AquaB LITE?

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

What is the FDA product code for AquaBplus; AquaB LITE?

The FDA product code for AquaBplus; AquaB LITE is FIP.

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Fonte oficial

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