FDA 510(k)

高级妇科应用器

K号: K161688 · 2017-01-27

决定日期2017-01-27

产品代码JAQ

咨询委员会RA

决定实质等同

器械摘要

Advanced Gynecological Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron B.V.. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K161688. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Advanced Gynecological Applicator?

Advanced Gynecological Applicator is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Nucletron B.V.. The 510(k) number is K161688.

When did Advanced Gynecological Applicator receive FDA 510(k) clearance?

Advanced Gynecological Applicator received FDA 510(k) clearance on 2017-01-27, under 510(k) number K161688.

Who is the listed applicant for Advanced Gynecological Applicator?

FDA 510(k)记录中列出Nucletron B.V.为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Advanced Gynecological Applicator?

The FDA product code for Advanced Gynecological Applicator is JAQ.

列明Nucletron B.V.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。

K262383LumenCare Azure K251037Rectal Applicator K213942Esteya K201272Geneva

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。