FDA 510(k)

笔式注射器

K号: K240774 · 2024-06-18

决定日期2024-06-18

产品代码FMF

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

Pen Injector is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Nest Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-18 under 510(k) number K240774. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pen Injector?

Pen Injector is a medical device that received FDA 510(k) clearance on 2024-06-18. The listed applicant is Wuxi Nest Biotechnology Co., Ltd.. The 510(k) number is K240774.

When did Pen Injector receive FDA 510(k) clearance?

Pen Injector received FDA 510(k) clearance on 2024-06-18, under 510(k) number K240774.

Who is the listed applicant for Pen Injector?

The FDA 510(k) record lists Wuxi Nest Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pen Injector?

The FDA product code for Pen Injector is FMF.

列明Wuxi Nest Biotechnology Co., Ltd.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。

K240961一次性笔式注射器组件 K211256一次性病毒运输培养基 K210440一次性灭活运输培养基，Nest ITM

相关器械（代码：FMF）

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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