FDA 510(k)

一次性注射针 AF 系列

K号: K230925 · 2023-09-27

申请人Alton (Shanghai) Medical Instruments Co., Ltd.

决定日期2023-09-27

产品代码FBK

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Disposable Injection Needle AF series is the device name listed in this FDA 510(k) record. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-09-27 under 510(k) number K230925. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Injection Needle AF series?

Disposable Injection Needle AF series is a medical device that received FDA 510(k) clearance on 2023-09-27. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K230925.

When did Disposable Injection Needle AF series receive FDA 510(k) clearance?

Disposable Injection Needle AF series received FDA 510(k) clearance on 2023-09-27, under 510(k) number K230925.

Who is the listed applicant for Disposable Injection Needle AF series?

The FDA 510(k) record lists Alton (Shanghai) Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Injection Needle AF series?

The FDA product code for Disposable Injection Needle AF series is FBK.

列明Alton (Shanghai) Medical Instruments 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。

K243039输尿管支架（AF-D系列）K242635内窥镜远端附件（AF-D系列）K241679一次性细胞刷（AF系列）K241285一次性内镜阀门组件套件（AF系列）K231633一次性止血夹（AF系列）

相关器械（代码：FBK）

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。

官方来源

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