FDA 510(k)

InMode 系統搭配 Fractora3D/3D-90 應用器

K 號：K180189 · 2018-06-01

決定日期2018-06-01

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

InMode System with Fractora3D/3D-90 Applicators is the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K180189. 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 InMode System with Fractora3D/3D-90 Applicators?

InMode System with Fractora3D/3D-90 Applicators is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K180189.

When did InMode System with Fractora3D/3D-90 Applicators receive FDA 510(k) clearance?

InMode System with Fractora3D/3D-90 Applicators received FDA 510(k) clearance on 2018-06-01, under 510(k) number K180189.

Who is the listed applicant for InMode System with Fractora3D/3D-90 Applicators?

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

What is the FDA product code for InMode System with Fractora3D/3D-90 Applicators?

The FDA product code for InMode System with Fractora3D/3D-90 Applicators is GEI.

其他以 Inmode MD , Ltd. 為申請人之記錄

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官方來源

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