FDA 510(k)

Mygen V-1000 電波系統

K 號：K180999 · 2018-12-11

決定日期2018-12-11

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 RF Medical Co., Ltd. 為申請人之記錄

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相關器械（代碼：GEI）

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