FDA 510(k)

3D Echo

Número K: K172513 · 2017-09-14

Data da decisão2017-09-14

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

3D Echo is the device name listed in this FDA 510(k) record. The listed applicant is Jointvue, LLC. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K172513. 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?

3D Echo is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is Jointvue, LLC. The 510(k) number is K172513.

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

3D Echo received FDA 510(k) clearance on 2017-09-14, under 510(k) number K172513.

Who is the listed applicant for 3D Echo?

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?

The FDA product code for 3D Echo 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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