FDA 510(k)

一次性内镜阀门系统

K号: K232244 · 2023-11-29

申请人Changzhou Endoclean Medical Device Co., Ltd.

决定日期2023-11-29

产品代码ODC

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 Endoscope Valves System is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Endoclean Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-11-29 under 510(k) number K232244. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Endoscope Valves System?

Disposable Endoscope Valves System is a medical device that received FDA 510(k) clearance on 2023-11-29. The listed applicant is Changzhou Endoclean Medical Device Co., Ltd.. The 510(k) number is K232244.

When did Disposable Endoscope Valves System receive FDA 510(k) clearance?

Disposable Endoscope Valves System received FDA 510(k) clearance on 2023-11-29, under 510(k) number K232244.

Who is the listed applicant for Disposable Endoscope Valves System?

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

What is the FDA product code for Disposable Endoscope Valves System?

The FDA product code for Disposable Endoscope Valves System is ODC.

列明Changzhou Endoclean Medical Device 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。

K221310内窥镜清洁连接管，内窥镜CO2源管 K221331一次性内镜阀门系统

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