SmartView 3D 选项
K号: K153429 · 2016-03-09
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器械摘要
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.
常见问题
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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相关器械（代码：JAK）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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