FDA 510(k)EZ-STIK 電極
K 號:K223775 · 2023-01-03
決定日期2023-01-03
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
EZ-STIK Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is South Dakota Partners. It received FDA 510(k) clearance on 2023-01-03 under 510(k) number K223775. 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 EZ-STIK Electrodes?
EZ-STIK Electrodes is a medical device that received FDA 510(k) clearance on 2023-01-03. The listed applicant is South Dakota Partners. The 510(k) number is K223775.
When did EZ-STIK Electrodes receive FDA 510(k) clearance?
EZ-STIK Electrodes received FDA 510(k) clearance on 2023-01-03, under 510(k) number K223775.
Who is the listed applicant for EZ-STIK Electrodes?
The FDA 510(k) record lists South Dakota Partners as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EZ-STIK Electrodes?
The FDA product code for EZ-STIK 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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