FDA 510(k)

塞瑞貝爾癲癇監測系統

K 號：K251936 · 2025-12-08

決定日期2025-12-08

產品代碼NCG

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

Ceribell Delirium Monitor System is the device name listed in this FDA 510(k) record. The listed applicant is Ceribell, Inc.. It received FDA 510(k) clearance on 2025-12-08 under 510(k) number K251936. The device is classified under product code NCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ceribell Delirium Monitor System?

Ceribell Delirium Monitor System is a medical device that received FDA 510(k) clearance on 2025-12-08. The listed applicant is Ceribell, Inc.. The 510(k) number is K251936.

When did Ceribell Delirium Monitor System receive FDA 510(k) clearance?

Ceribell Delirium Monitor System received FDA 510(k) clearance on 2025-12-08, under 510(k) number K251936.

Who is the listed applicant for Ceribell Delirium Monitor System?

FDA 510(k) 記錄將 Ceribell, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Ceribell Delirium Monitor System?

The FDA product code for Ceribell Delirium Monitor System is NCG.

其他以 Ceribell, Inc. 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。

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相關器械（代碼：NCG）

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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官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。