FDA 510(k)

IB3D ALIF

Número K: K191134 · 2019-10-30

Data da decisão2019-10-30

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

IB3D ALIF is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International SA. It received FDA 510(k) clearance on 2019-10-30 under 510(k) number K191134. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IB3D ALIF?

IB3D ALIF is a medical device that received FDA 510(k) clearance on 2019-10-30. The listed applicant is Medicrea International SA. The 510(k) number is K191134.

When did IB3D ALIF receive FDA 510(k) clearance?

IB3D ALIF received FDA 510(k) clearance on 2019-10-30, under 510(k) number K191134.

Who is the listed applicant for IB3D ALIF?

The FDA 510(k) record lists Medicrea International SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IB3D ALIF?

The FDA product code for IB3D ALIF is MAX.

Outros registros que listam Medicrea International SA como candidato(a)

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Fonte oficial

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