FDA 510(k)

電子脈衝刺激器

K 號：K153520 · 2016-05-05

決定日期2016-05-05

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

Electronic Pulse Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K153520. 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 Electronic Pulse Stimulator?

Electronic Pulse Stimulator is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Jkh Health Co., Ltd.. The 510(k) number is K153520.

When did Electronic Pulse Stimulator receive FDA 510(k) clearance?

Electronic Pulse Stimulator received FDA 510(k) clearance on 2016-05-05, under 510(k) number K153520.

Who is the listed applicant for Electronic Pulse Stimulator?

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

What is the FDA product code for Electronic Pulse Stimulator?

The FDA product code for Electronic Pulse Stimulator is NUH.

其他以 Jkh Health 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。

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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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