CardioSTAT® 心電圖測試解決方案
K 號：K223049 · 2023-03-22
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器材摘要
CardioSTAT® ECG Test Solution is the device name listed in this FDA 510(k) record. The listed applicant is Icentia, Inc.. It received FDA 510(k) clearance on 2023-03-22 under 510(k) number K223049. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CardioSTAT® ECG Test Solution?
CardioSTAT® ECG Test Solution is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Icentia, Inc.. The 510(k) number is K223049.
When did CardioSTAT® ECG Test Solution receive FDA 510(k) clearance?
CardioSTAT® ECG Test Solution received FDA 510(k) clearance on 2023-03-22, under 510(k) number K223049.
Who is the listed applicant for CardioSTAT® ECG Test Solution?
The FDA 510(k) record lists Icentia, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CardioSTAT® ECG Test Solution?
The FDA product code for CardioSTAT® ECG Test Solution is DSH.
相關臨床試驗
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相關器械（代碼：DSH）
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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