FDA 510(k)

3D Echo v1.1

Número K: K211656 · 2021-06-25

Data da decisão2021-06-25

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

3D Echo v1.1 is the device name listed in this FDA 510(k) record. The listed applicant is Jointvue, LLC. It received FDA 510(k) clearance on 2021-06-25 under 510(k) number K211656. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 3D Echo v1.1?

3D Echo v1.1 is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Jointvue, LLC. The 510(k) number is K211656.

When did 3D Echo v1.1 receive FDA 510(k) clearance?

3D Echo v1.1 received FDA 510(k) clearance on 2021-06-25, under 510(k) number K211656.

Who is the listed applicant for 3D Echo v1.1?

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

What is the FDA product code for 3D Echo v1.1?

The FDA product code for 3D Echo v1.1 is LLZ.

Outros registros que listam Jointvue, LLC 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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