FDA 510(k)

ZOOM

Número K: K172768 · 2018-04-24

RequerenteZetta Medical Technologies, LLC

Data da decisão2018-04-24

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ZOOM is the device name listed in this FDA 510(k) record. The listed applicant is Zetta Medical Technologies, LLC. It received FDA 510(k) clearance on 2018-04-24 under 510(k) number K172768. 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 ZOOM?

ZOOM is a medical device that received FDA 510(k) clearance on 2018-04-24. The listed applicant is Zetta Medical Technologies, LLC. The 510(k) number is K172768.

When did ZOOM receive FDA 510(k) clearance?

ZOOM received FDA 510(k) clearance on 2018-04-24, under 510(k) number K172768.

Who is the listed applicant for ZOOM?

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

What is the FDA product code for ZOOM?

The FDA product code for ZOOM is LLZ.

Outros registros que listam Zetta Medical Technologies, 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.

K170273Z-DOSE29 K160852Zia

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Fonte oficial

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