FDA 510(k)

CS 9600

Número K: K181136 · 2018-05-24

RequerenteTrophy

Data da decisão2018-05-24

Código do produtoOAS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

CS 9600 is the device name listed in this FDA 510(k) record. The listed applicant is Trophy. It received FDA 510(k) clearance on 2018-05-24 under 510(k) number K181136. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CS 9600?

CS 9600 is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Trophy. The 510(k) number is K181136.

When did CS 9600 receive FDA 510(k) clearance?

CS 9600 received FDA 510(k) clearance on 2018-05-24, under 510(k) number K181136.

Who is the listed applicant for CS 9600?

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

What is the FDA product code for CS 9600?

The FDA product code for CS 9600 is OAS.

Outros registros que listam Trophy 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.

K193390CS Model+K200183CS 9600 K173622CS Imaging

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Fonte oficial

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