ARC 重症監護資訊系統 (ARC 系統)
K 號：K220117 · 2023-06-06
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器材摘要
ARC Intensive Care Information System (ARC System) is the device name listed in this FDA 510(k) record. The listed applicant is Ordinatrum Solutions. It received FDA 510(k) clearance on 2023-06-06 under 510(k) number K220117. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ARC Intensive Care Information System (ARC System)?
ARC Intensive Care Information System (ARC System) is a medical device that received FDA 510(k) clearance on 2023-06-06. The listed applicant is Ordinatrum Solutions. The 510(k) number is K220117.
When did ARC Intensive Care Information System (ARC System) receive FDA 510(k) clearance?
ARC Intensive Care Information System (ARC System) received FDA 510(k) clearance on 2023-06-06, under 510(k) number K220117.
Who is the listed applicant for ARC Intensive Care Information System (ARC System)?
The FDA 510(k) record lists Ordinatrum Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ARC Intensive Care Information System (ARC System)?
The FDA product code for ARC Intensive Care Information System (ARC System) is MWI.
相關臨床試驗
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相關器械（代碼：MWI）
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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