包裝附屬電極
K 號：K190617 · 2019-07-02
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器材摘要
Wrap accessory electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2019-07-02 under 510(k) number K190617. 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 Wrap accessory electrodes?
Wrap accessory electrodes is a medical device that received FDA 510(k) clearance on 2019-07-02. The listed applicant is Hi-Dow International, Inc.. The 510(k) number is K190617.
When did Wrap accessory electrodes receive FDA 510(k) clearance?
Wrap accessory electrodes received FDA 510(k) clearance on 2019-07-02, under 510(k) number K190617.
Who is the listed applicant for Wrap accessory electrodes?
The FDA 510(k) record lists Hi-Dow International, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Wrap accessory electrodes?
The FDA product code for Wrap accessory electrodes is GXY.
相關臨床試驗
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其他以 Hi-Dow International, Inc. 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。
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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官方來源
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