FDA 510(k)經皮電神經刺激器
K 號：K200237 · 2020-10-19
決定日期2020-10-19
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
Transcutaneous Electronic Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-10-19 under 510(k) number K200237. 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 Transcutaneous Electronic Nerve Stimulator?
Transcutaneous Electronic Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2020-10-19. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K200237.
When did Transcutaneous Electronic Nerve Stimulator receive FDA 510(k) clearance?
Transcutaneous Electronic Nerve Stimulator received FDA 510(k) clearance on 2020-10-19, under 510(k) number K200237.
Who is the listed applicant for Transcutaneous Electronic Nerve Stimulator?
The FDA 510(k) record lists Shenzhen Kentro Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Transcutaneous Electronic Nerve Stimulator?
The FDA product code for Transcutaneous Electronic Nerve Stimulator is NUH.
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其他以 Shenzhen Kentro Medical Electronics Co., Ltd. 為申請人之記錄
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