FDA 510(k)

达芬奇Xi手术系统

K号: K151794 · 2016-01-15

决定日期2016-01-15

产品代码NAY

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决定实质等同

器械摘要

da Vinci Xi Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K151794. The device is classified under product code NAY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the da Vinci Xi Surgical System?

da Vinci Xi Surgical System is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K151794.

When did da Vinci Xi Surgical System receive FDA 510(k) clearance?

da Vinci Xi Surgical System received FDA 510(k) clearance on 2016-01-15, under 510(k) number K151794.

Who is the listed applicant for da Vinci Xi Surgical System?

FDA 510(k)记录中列出了Intuitive Surgical, Inc.为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for da Vinci Xi Surgical System?

The FDA product code for da Vinci Xi Surgical System is NAY.

列明Intuitive Surgical, Inc.为申报人的其他记录

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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官方来源

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