FDA 510(k)

JKH 刺激器 Plus

K 號：K191151 · 2019-06-21

決定日期2019-06-21

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

JKH Stimulator Plus is the device name listed in this FDA 510(k) record. The listed applicant is Jkh USA, LLC. It received FDA 510(k) clearance on 2019-06-21 under 510(k) number K191151. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the JKH Stimulator Plus?

JKH Stimulator Plus is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Jkh USA, LLC. The 510(k) number is K191151.

When did JKH Stimulator Plus receive FDA 510(k) clearance?

JKH Stimulator Plus received FDA 510(k) clearance on 2019-06-21, under 510(k) number K191151.

Who is the listed applicant for JKH Stimulator Plus?

The FDA 510(k) record lists Jkh USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JKH Stimulator Plus?

The FDA product code for JKH Stimulator Plus is NUH.

其他以 Jkh USA, LLC 為申請人之記錄

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相關器械（代碼：NUH）

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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