FDA 510(k)

Aurora

Número K: K251153 · 2025-06-12

Data da decisão2025-06-12

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aurora is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Israel. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K251153. 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 Aurora?

Aurora is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Ge Medical Systems Israel. The 510(k) number is K251153.

When did Aurora receive FDA 510(k) clearance?

Aurora received FDA 510(k) clearance on 2025-06-12, under 510(k) number K251153.

Who is the listed applicant for Aurora?

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

What is the FDA product code for Aurora?

The FDA product code for Aurora is KPS.

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Dispositivos Relacionados (Código: KPS)

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