FDA 510(k)

ExactVu High Resolution Micro-Ultrasound System

Número K: K190995 · 2019-05-10

Data da decisão2019-05-10

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ExactVu High Resolution Micro-Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Exact Imaging, Inc.. It received FDA 510(k) clearance on 2019-05-10 under 510(k) number K190995. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ExactVu High Resolution Micro-Ultrasound System?

ExactVu High Resolution Micro-Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-05-10. The listed applicant is Exact Imaging, Inc.. The 510(k) number is K190995.

When did ExactVu High Resolution Micro-Ultrasound System receive FDA 510(k) clearance?

ExactVu High Resolution Micro-Ultrasound System received FDA 510(k) clearance on 2019-05-10, under 510(k) number K190995.

Who is the listed applicant for ExactVu High Resolution Micro-Ultrasound System?

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

What is the FDA product code for ExactVu High Resolution Micro-Ultrasound System?

The FDA product code for ExactVu High Resolution Micro-Ultrasound System is IYN.

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Outros registros que listam Exact Imaging, Inc. como candidato(a)

K192303ExactVu High Resolution Micro-Ultrasound System K180636ExactVu High Resolution Micro-Ultrasound System

Dispositivos Relacionados (Código: IYN)

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