FDA 510(k)

带织物袋的实验室包

K号: K210248 · 2021-07-30

决定日期2021-07-30

产品代码GCJ

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决定实质等同

器械摘要

Lab Bag with Fabric Pouch is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Design Co., Ltd.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K210248. 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 Lab Bag with Fabric Pouch?

Lab Bag with Fabric Pouch is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Advanced Medical Design Co., Ltd.. The 510(k) number is K210248.

When did Lab Bag with Fabric Pouch receive FDA 510(k) clearance?

Lab Bag with Fabric Pouch received FDA 510(k) clearance on 2021-07-30, under 510(k) number K210248.

Who is the listed applicant for Lab Bag with Fabric Pouch?

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

What is the FDA product code for Lab Bag with Fabric Pouch?

The FDA product code for Lab Bag with Fabric Pouch is GCJ.

列明Advanced Medical Design 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。

K181887AMD 防雾溶液

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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