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FDA 510(k)

MR條件式杯電極

K 號:K254183 · 2026-05-07

決定日期2026-05-07
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

MR Conditional Cup Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Technomed Europe. It received FDA 510(k) clearance on 2026-05-07 under 510(k) number K254183. 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 MR Conditional Cup Electrodes?

MR Conditional Cup Electrodes is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Technomed Europe. The 510(k) number is K254183.

When did MR Conditional Cup Electrodes receive FDA 510(k) clearance?

MR Conditional Cup Electrodes received FDA 510(k) clearance on 2026-05-07, under 510(k) number K254183.

Who is the listed applicant for MR Conditional Cup Electrodes?

The FDA 510(k) record lists Technomed Europe as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MR Conditional Cup Electrodes?

The FDA product code for MR Conditional Cup Electrodes 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。

其他以 Technomed Europe 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。

官方來源

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