塞瑞貝爾大腦監測頭帶
K 號：K260363 · 2026-04-03
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器材摘要
Ceribell Brain Monitor Headband is the device name listed in this FDA 510(k) record. The listed applicant is Ceribell, Inc.. It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K260363. 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 Ceribell Brain Monitor Headband?
Ceribell Brain Monitor Headband is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is Ceribell, Inc.. The 510(k) number is K260363.
When did Ceribell Brain Monitor Headband receive FDA 510(k) clearance?
Ceribell Brain Monitor Headband received FDA 510(k) clearance on 2026-04-03, under 510(k) number K260363.
Who is the listed applicant for Ceribell Brain Monitor Headband?
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 Brain Monitor Headband?
The FDA product code for Ceribell Brain Monitor Headband is GXY.
相關臨床試驗
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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。
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。
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官方來源
在 FDA 資料庫中查看 →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。
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