AeroEclipse* ONE BAN
K 號：K200063 · 2020-07-17
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器材摘要
AeroEclipse* ONE BAN is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical International. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K200063. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AeroEclipse* ONE BAN?
AeroEclipse* ONE BAN is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Trudell Medical International. The 510(k) number is K200063.
When did AeroEclipse* ONE BAN receive FDA 510(k) clearance?
AeroEclipse* ONE BAN received FDA 510(k) clearance on 2020-07-17, under 510(k) number K200063.
Who is the listed applicant for AeroEclipse* ONE BAN?
The FDA 510(k) record lists Trudell Medical International as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AeroEclipse* ONE BAN?
The FDA product code for AeroEclipse* ONE BAN is CAF.
相關臨床試驗
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其他以 Trudell Medical International 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：CAF）
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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