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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.

相關臨床試驗

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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。

官方來源

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