FDA 510(k)

Hamilton-G5

Número K: K180295 · 2019-07-30

Data da decisão2019-07-30

Código do produtoCBK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hamilton-G5 is the device name listed in this FDA 510(k) record. The listed applicant is Hamiton Medical AG. It received FDA 510(k) clearance on 2019-07-30 under 510(k) number K180295. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Hamilton-G5?

Hamilton-G5 is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Hamiton Medical AG. The 510(k) number is K180295.

When did Hamilton-G5 receive FDA 510(k) clearance?

Hamilton-G5 received FDA 510(k) clearance on 2019-07-30, under 510(k) number K180295.

Who is the listed applicant for Hamilton-G5?

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

What is the FDA product code for Hamilton-G5?

The FDA product code for Hamilton-G5 is CBK.

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