FDA 510(k)

Ceribell 癲癇偵測軟體

K 號：K241589 · 2025-04-09

決定日期2025-04-09

產品代碼OMB

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 Seizure Detection Software is the device name listed in this FDA 510(k) record. The listed applicant is Ceribell, Inc.. It received FDA 510(k) clearance on 2025-04-09 under 510(k) number K241589. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ceribell Seizure Detection Software?

Ceribell Seizure Detection Software is a medical device that received FDA 510(k) clearance on 2025-04-09. The listed applicant is Ceribell, Inc.. The 510(k) number is K241589.

When did Ceribell Seizure Detection Software receive FDA 510(k) clearance?

Ceribell Seizure Detection Software received FDA 510(k) clearance on 2025-04-09, under 510(k) number K241589.

Who is the listed applicant for Ceribell Seizure Detection Software?

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 Seizure Detection Software?

The FDA product code for Ceribell Seizure Detection Software is OMB.

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。

K261712塞瑞貝爾電腦神經電圖分析軟體 K261101塞瑞貝爾監護器 K260998塞瑞貝爾神經學評估軟體 K260363塞瑞貝爾大腦監測頭帶 K254033塞瑞貝爾即時電腦輔助電腦頭戴式電腦輔助設備 K251936塞瑞貝爾癲癇監測系統

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相關器械（代碼：OMB）

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。

K260998塞瑞貝爾神經學評估軟體Ceribell, Inc.K252070Ceribell嬰兒癲癇偵測軟體Ceribell, Inc.K252160Persyst 15 腦電圖評估与分析軟體（Persyst 15 (P15)）Persyst Development, LLC K243743autoSCORE (V 2.0.0)Holberg Eeg AS K242446Persyst 15 腦電圖評估与分析軟體（Persyst 15 (P15)）Persyst Development Corporation K241390神經匹配LVIS Corporation

官方來源

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