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FDA 510(k)

神經刀系統

K 號:K230125 · 2023-10-13

決定日期2023-10-13
產品代碼GWG
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

Neuroblade System is the device name listed in this FDA 510(k) record. The listed applicant is Clearmind Biomedical. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K230125. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neuroblade System?

Neuroblade System is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Clearmind Biomedical. The 510(k) number is K230125.

When did Neuroblade System receive FDA 510(k) clearance?

Neuroblade System received FDA 510(k) clearance on 2023-10-13, under 510(k) number K230125.

Who is the listed applicant for Neuroblade System?

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

What is the FDA product code for Neuroblade System?

The FDA product code for Neuroblade System is GWG.

相關臨床試驗

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其他以 Clearmind Biomedical 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:GWG)

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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