FDA 510(k)

Orbit 插入器

K号: K163400 · 2017-07-26

决定日期2017-07-26

产品代码KZH

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Orbit Inserter is the device name listed in this FDA 510(k) record. The listed applicant is Ypsomed AG. It received FDA 510(k) clearance on 2017-07-26 under 510(k) number K163400. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Orbit Inserter?

Orbit Inserter is a medical device that received FDA 510(k) clearance on 2017-07-26. The listed applicant is Ypsomed AG. The 510(k) number is K163400.

When did Orbit Inserter receive FDA 510(k) clearance?

Orbit Inserter received FDA 510(k) clearance on 2017-07-26, under 510(k) number K163400.

Who is the listed applicant for Orbit Inserter?

The FDA 510(k) record lists Ypsomed AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orbit Inserter?

The FDA product code for Orbit Inserter is KZH.

列明Ypsomed AG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。

K243901SmartPilot YpsoMate NS-A2.25 K171984Clickfine 针笔，Penfine 经典针笔 K150921Orbit 注射器

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。