FDA 510(k)

AGNES

K 號：K160469 · 2017-01-05

決定日期2017-01-05

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

AGNES is the device name listed in this FDA 510(k) record. The listed applicant is Gowoonsesang Cosmetics Co., Ltd.. It received FDA 510(k) clearance on 2017-01-05 under 510(k) number K160469. 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 AGNES?

AGNES is a medical device that received FDA 510(k) clearance on 2017-01-05. The listed applicant is Gowoonsesang Cosmetics Co., Ltd.. The 510(k) number is K160469.

When did AGNES receive FDA 510(k) clearance?

AGNES received FDA 510(k) clearance on 2017-01-05, under 510(k) number K160469.

Who is the listed applicant for AGNES?

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

What is the FDA product code for AGNES?

The FDA product code for AGNES is GEI.

其他以 Gowoonsesang Cosmetics Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K171707GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A

相關器械（代碼：GEI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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