FDA 510(k)

Mygen V-1000 RF 系统

K号: K180999 · 2018-12-11

决定日期2018-12-11

产品代码GEI

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决定实质等同

器械摘要

Mygen V-1000 RF System is the device name listed in this FDA 510(k) record. The listed applicant is RF Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-12-11 under 510(k) number K180999. 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 Mygen V-1000 RF System?

Mygen V-1000 RF System is a medical device that received FDA 510(k) clearance on 2018-12-11. The listed applicant is RF Medical Co., Ltd.. The 510(k) number is K180999.

When did Mygen V-1000 RF System receive FDA 510(k) clearance?

Mygen V-1000 RF System received FDA 510(k) clearance on 2018-12-11, under 510(k) number K180999.

Who is the listed applicant for Mygen V-1000 RF System?

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

What is the FDA product code for Mygen V-1000 RF System?

The FDA product code for Mygen V-1000 RF System is GEI.

列明RF Medical 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。

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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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