FDA 510(k)

MAMMI

Número K: K161631 · 2016-07-28

RequerenteGeneral Equipment For Medical Imaging

Data da decisão2016-07-28

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

MAMMI is the device name listed in this FDA 510(k) record. The listed applicant is General Equipment For Medical Imaging. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161631. 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 MAMMI?

MAMMI is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is General Equipment For Medical Imaging. The 510(k) number is K161631.

When did MAMMI receive FDA 510(k) clearance?

MAMMI received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161631.

Who is the listed applicant for MAMMI?

The FDA 510(k) record lists General Equipment For Medical Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMMI?

The FDA product code for MAMMI is KPS.

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Dispositivos Relacionados (Código: KPS)

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