FDA 510(k)

Novalung ultimate kit (US)

Número K: K232926 · 2024-04-15

RequerenteFresenius Medical Care Renal Therapies Group, LLC

Data da decisão2024-04-15

Código do produtoQJZ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Novalung ultimate kit (US) 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 2024-04-15 under 510(k) number K232926. The device is classified under product code QJZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Novalung ultimate kit (US)?

Novalung ultimate kit (US) is a medical device that received FDA 510(k) clearance on 2024-04-15. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K232926.

When did Novalung ultimate kit (US) receive FDA 510(k) clearance?

Novalung ultimate kit (US) received FDA 510(k) clearance on 2024-04-15, under 510(k) number K232926.

Who is the listed applicant for Novalung ultimate kit (US)?

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 Novalung ultimate kit (US)?

The FDA product code for Novalung ultimate kit (US) is QJZ.

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Fonte oficial

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