FDA 510(k)

一次性笔式注射器组件

K号: K240961 · 2024-08-15

决定日期2024-08-15

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

Disposable Pen Injector Assembly 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 2024-08-15 under 510(k) number K240961. 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 Disposable Pen Injector Assembly?

Disposable Pen Injector Assembly is a medical device that received FDA 510(k) clearance on 2024-08-15. The listed applicant is Wuxi Nest Biotechnology Co., Ltd.. The 510(k) number is K240961.

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

Disposable Pen Injector Assembly received FDA 510(k) clearance on 2024-08-15, under 510(k) number K240961.

Who is the listed applicant for Disposable Pen Injector Assembly?

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 Disposable Pen Injector Assembly?

The FDA product code for Disposable Pen Injector Assembly 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。

K240774笔式注射器 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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