FDA 510(k)

Fresenius Liberty Select Cycler

Número K: K222318 · 2022-10-31

RequerenteFresenius Medical Care Renal Therapies Group, LLC

Data da decisão2022-10-31

Código do produtoFKX

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fresenius Liberty Select Cycler 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 2022-10-31 under 510(k) number K222318. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fresenius Liberty Select Cycler?

Fresenius Liberty Select Cycler is a medical device that received FDA 510(k) clearance on 2022-10-31. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K222318.

When did Fresenius Liberty Select Cycler receive FDA 510(k) clearance?

Fresenius Liberty Select Cycler received FDA 510(k) clearance on 2022-10-31, under 510(k) number K222318.

Who is the listed applicant for Fresenius Liberty Select Cycler?

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 Fresenius Liberty Select Cycler?

The FDA product code for Fresenius Liberty Select Cycler is FKX.

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Fonte oficial

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