FDA 510(k)

ImagenUniversal

Número K: K173547 · 2018-01-12

RequerenteCardiovascular Imaging Technologies

Data da decisão2018-01-12

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ImagenUniversal is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Imaging Technologies. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K173547. 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 ImagenUniversal?

ImagenUniversal is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Cardiovascular Imaging Technologies. The 510(k) number is K173547.

When did ImagenUniversal receive FDA 510(k) clearance?

ImagenUniversal received FDA 510(k) clearance on 2018-01-12, under 510(k) number K173547.

Who is the listed applicant for ImagenUniversal?

The FDA 510(k) record lists Cardiovascular Imaging Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ImagenUniversal?

The FDA product code for ImagenUniversal is KPS.

Ensaios clínicos relacionados

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Outros registros que listam Cardiovascular Imaging Technologies como candidato(a)

K201933ImagenSPECT 3.0 K152503ImagenSPECT

Dispositivos Relacionados (Código: KPS)

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