血濾系統
K 號：K210862 · 2021-07-29
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器材摘要
Hemafuse System is the device name listed in this FDA 510(k) record. The listed applicant is Sisu Global Health. It received FDA 510(k) clearance on 2021-07-29 under 510(k) number K210862. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Hemafuse System?
Hemafuse System is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Sisu Global Health. The 510(k) number is K210862.
When did Hemafuse System receive FDA 510(k) clearance?
Hemafuse System received FDA 510(k) clearance on 2021-07-29, under 510(k) number K210862.
Who is the listed applicant for Hemafuse System?
The FDA 510(k) record lists Sisu Global Health as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hemafuse System?
The FDA product code for Hemafuse System is CAC.
相關臨床試驗
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相關器械（代碼：CAC）
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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