FDA 510(k)

qXR-LN

Número K: K231805 · 2023-12-22

Data da decisão2023-12-22

Código do produtoMYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

qXR-LN is the device name listed in this FDA 510(k) record. The listed applicant is Qure.Ai Technologies. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K231805. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the qXR-LN?

qXR-LN is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Qure.Ai Technologies. The 510(k) number is K231805.

When did qXR-LN receive FDA 510(k) clearance?

qXR-LN received FDA 510(k) clearance on 2023-12-22, under 510(k) number K231805.

Who is the listed applicant for qXR-LN?

The FDA 510(k) record lists Qure.Ai Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for qXR-LN?

The FDA product code for qXR-LN is MYN.

Outros registros que listam Qure.Ai Technologies como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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