FDA 510(k)

一次性冲洗双极电缆

K号: K211170 · 2021-10-19

申请人Modern Medical Equipment Manufacturing, Ltd.

决定日期2021-10-19

产品代码GEI

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决定实质等同

器械摘要

Single Use Irrigation bipolar cable is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Manufacturing, Ltd.. It received FDA 510(k) clearance on 2021-10-19 under 510(k) number K211170. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Single Use Irrigation bipolar cable?

Single Use Irrigation bipolar cable is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Modern Medical Equipment Manufacturing, Ltd.. The 510(k) number is K211170.

When did Single Use Irrigation bipolar cable receive FDA 510(k) clearance?

Single Use Irrigation bipolar cable received FDA 510(k) clearance on 2021-10-19, under 510(k) number K211170.

Who is the listed applicant for Single Use Irrigation bipolar cable?

The FDA 510(k) record lists Modern Medical Equipment Manufacturing, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Irrigation bipolar cable?

The FDA product code for Single Use Irrigation bipolar cable is GEI.

列明Modern Medical Equipment Manufacturing, 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。

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相关器械（代码：GEI）

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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