FDA 510(k)

SmartView 3D Option

Número K: K153429 · 2016-03-09

RequerenteGe Hangwei Medical System Co., Ltd.

Data da decisão2016-03-09

Código do produtoJAK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

SmartView 3D Option is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hangwei Medical System Co., Ltd.. It received FDA 510(k) clearance on 2016-03-09 under 510(k) number K153429. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SmartView 3D Option?

SmartView 3D Option is a medical device that received FDA 510(k) clearance on 2016-03-09. The listed applicant is Ge Hangwei Medical System Co., Ltd.. The 510(k) number is K153429.

When did SmartView 3D Option receive FDA 510(k) clearance?

SmartView 3D Option received FDA 510(k) clearance on 2016-03-09, under 510(k) number K153429.

Who is the listed applicant for SmartView 3D Option?

The FDA 510(k) record lists Ge Hangwei Medical System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartView 3D Option?

The FDA product code for SmartView 3D Option is JAK.

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