FDA 510(k)Adhesive Electrodes
K 號:K212191 · 2021-10-06
決定日期2021-10-06
產品代碼GXY
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
Adhesive Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Voncare Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-10-06 under 510(k) number K212191. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Adhesive Electrodes?
Adhesive Electrodes is a medical device that received FDA 510(k) clearance on 2021-10-06. The listed applicant is Voncare Medical Device Co., Ltd.. The 510(k) number is K212191.
When did Adhesive Electrodes receive FDA 510(k) clearance?
Adhesive Electrodes received FDA 510(k) clearance on 2021-10-06, under 510(k) number K212191.
Who is the listed applicant for Adhesive Electrodes?
The FDA 510(k) record lists Voncare Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Adhesive Electrodes?
The FDA product code for Adhesive Electrodes is GXY.
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相關器械(代碼:GXY)
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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