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FDA 510(k)

X-trodes 系統 M

K 號:K232210 · 2024-02-04

申請人X-Trodes
決定日期2024-02-04
產品代碼GWL
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

X-trodes System M is the device name listed in this FDA 510(k) record. The listed applicant is X-Trodes. It received FDA 510(k) clearance on 2024-02-04 under 510(k) number K232210. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the X-trodes System M?

X-trodes System M is a medical device that received FDA 510(k) clearance on 2024-02-04. The listed applicant is X-Trodes. The 510(k) number is K232210.

When did X-trodes System M receive FDA 510(k) clearance?

X-trodes System M received FDA 510(k) clearance on 2024-02-04, under 510(k) number K232210.

Who is the listed applicant for X-trodes System M?

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

What is the FDA product code for X-trodes System M?

The FDA product code for X-trodes System M is GWL.

相關臨床試驗

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相關器械(代碼:GWL)

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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