FDA 510(k)

Symbia 6.5

Número K: K162337 · 2016-09-08

RequerenteSiemens Medical Solutions USA, Inc.

Data da decisão2016-09-08

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Symbia 6.5 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K162337. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Symbia 6.5?

Symbia 6.5 is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K162337.

When did Symbia 6.5 receive FDA 510(k) clearance?

Symbia 6.5 received FDA 510(k) clearance on 2016-09-08, under 510(k) number K162337.

Who is the listed applicant for Symbia 6.5?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Symbia 6.5?

The FDA product code for Symbia 6.5 is KPS.

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Fonte oficial

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