FDA 510(k)

一次性微电极（黄铜带镀金柄）；一次性微电极（不锈钢柄）

K号: K163442 · 2017-09-28

申请人Modern Medical Equipment Manufacturing Limited

决定日期2017-09-28

产品代码GEI

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决定实质等同

器械摘要

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Manufacturing Limited. It received FDA 510(k) clearance on 2017-09-28 under 510(k) number K163442. 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 Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)?

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Modern Medical Equipment Manufacturing Limited. The 510(k) number is K163442.

When did Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) receive FDA 510(k) clearance?

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) received FDA 510(k) clearance on 2017-09-28, under 510(k) number K163442.

Who is the listed applicant for Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)?

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

What is the FDA product code for Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)?

The FDA product code for Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) is GEI.

列明Modern Medical Equipment Manufacturing Limited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。

K170703一次性关节镜电极（带铅笔）K152059一次性通用电极

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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