Brainomix 360 緊急分類中風
K 號：K251983 · 2025-08-26
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器材摘要
Brainomix 360 Triage Stroke is the device name listed in this FDA 510(k) record. The listed applicant is Brainomix Limited. It received FDA 510(k) clearance on 2025-08-26 under 510(k) number K251983. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Brainomix 360 Triage Stroke?
Brainomix 360 Triage Stroke is a medical device that received FDA 510(k) clearance on 2025-08-26. The listed applicant is Brainomix Limited. The 510(k) number is K251983.
When did Brainomix 360 Triage Stroke receive FDA 510(k) clearance?
Brainomix 360 Triage Stroke received FDA 510(k) clearance on 2025-08-26, under 510(k) number K251983.
Who is the listed applicant for Brainomix 360 Triage Stroke?
The FDA 510(k) record lists Brainomix Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Brainomix 360 Triage Stroke?
The FDA product code for Brainomix 360 Triage Stroke is QAS.
相關臨床試驗
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其他以 Brainomix Limited 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：QAS）
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
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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