FDA 510(k)

Alexis 封闭式提取系统

K号: K211043 · 2022-03-31

申请人Applied Medical Resources Corporation

决定日期2022-03-31

产品代码GCJ

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决定实质等同

器械摘要

Alexis Contained Extraction System is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2022-03-31 under 510(k) number K211043. 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 Alexis Contained Extraction System?

Alexis Contained Extraction System is a medical device that received FDA 510(k) clearance on 2022-03-31. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K211043.

When did Alexis Contained Extraction System receive FDA 510(k) clearance?

Alexis Contained Extraction System received FDA 510(k) clearance on 2022-03-31, under 510(k) number K211043.

Who is the listed applicant for Alexis Contained Extraction System?

The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alexis Contained Extraction System?

The FDA product code for Alexis Contained Extraction System is GCJ.

列明Applied Medical Resources Corporation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。

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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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