FDA 510(k)

样品检索袋

K号: K172789 · 2018-02-01

申请人Beijing Hangtian Kadi Technology R&D Institute

决定日期2018-02-01

产品代码GCJ

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

Specimen Retrieval Bag is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Hangtian Kadi Technology R&D Institute. It received FDA 510(k) clearance on 2018-02-01 under 510(k) number K172789. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Specimen Retrieval Bag?

Specimen Retrieval Bag is a medical device that received FDA 510(k) clearance on 2018-02-01. The listed applicant is Beijing Hangtian Kadi Technology R&D Institute. The 510(k) number is K172789.

When did Specimen Retrieval Bag receive FDA 510(k) clearance?

Specimen Retrieval Bag received FDA 510(k) clearance on 2018-02-01, under 510(k) number K172789.

Who is the listed applicant for Specimen Retrieval Bag?

The FDA 510(k) record lists Beijing Hangtian Kadi Technology R&D Institute as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Specimen Retrieval Bag?

The FDA product code for Specimen Retrieval Bag is GCJ.

列明Beijing Hangtian Kadi Technology R&D Institute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。

K172846子宫操作器

相关器械（代码：GCJ）

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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