FDA 510(k)

Trinias

Número K: K203535 · 2021-04-28

RequerenteShimadzu Corporation Medical Systems

Data da decisão2021-04-28

Código do produtoOWB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Trinias is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corporation Medical Systems. It received FDA 510(k) clearance on 2021-04-28 under 510(k) number K203535. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Trinias?

Trinias is a medical device that received FDA 510(k) clearance on 2021-04-28. The listed applicant is Shimadzu Corporation Medical Systems. The 510(k) number is K203535.

When did Trinias receive FDA 510(k) clearance?

Trinias received FDA 510(k) clearance on 2021-04-28, under 510(k) number K203535.

Who is the listed applicant for Trinias?

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

What is the FDA product code for Trinias?

The FDA product code for Trinias is OWB.

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