FDA 510(k)

Discovery MI

Número K: K161574 · 2016-08-11

Data da decisão2016-08-11

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Discovery MI is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K161574. 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 Discovery MI?

Discovery MI is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K161574.

When did Discovery MI receive FDA 510(k) clearance?

Discovery MI received FDA 510(k) clearance on 2016-08-11, under 510(k) number K161574.

Who is the listed applicant for Discovery MI?

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

What is the FDA product code for Discovery MI?

The FDA product code for Discovery MI is KPS.

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Fonte oficial

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