自粘電極
K 號：K181234 · 2018-08-07
廣告
決定日期2018-08-07
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
Self-adhesive Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Dong Guan OU Kang Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-08-07 under 510(k) number K181234. 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 Self-adhesive Electrode?
Self-adhesive Electrode is a medical device that received FDA 510(k) clearance on 2018-08-07. The listed applicant is Dong Guan OU Kang Electronics Co., Ltd.. The 510(k) number is K181234.
When did Self-adhesive Electrode receive FDA 510(k) clearance?
Self-adhesive Electrode received FDA 510(k) clearance on 2018-08-07, under 510(k) number K181234.
Who is the listed applicant for Self-adhesive Electrode?
The FDA 510(k) record lists Dong Guan OU Kang Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Self-adhesive Electrode?
The FDA product code for Self-adhesive Electrode is GXY.
相關臨床試驗
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。
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。
K262654Dexus假肢系統（MSL2，MSR2）Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (型號72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (型號72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (型號72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442夏洛特ACC25表面電極陣列；夏洛特ACC25可重用表面電極陣列Cadwell Industries, Inc.K261522生物波生物包Biowave CorporationK253237Elde醫療電極（T5/ 5公分 x 5公分電極 T10/ 5公分 x 10公分電極）Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR條件式杯電極Technomed Europe
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
廣告