科傑心動監測系統
K 號：K152006 · 2016-05-05
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器材摘要
Cogent Hemodynamic Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K152006. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Cogent Hemodynamic Monitoring System?
Cogent Hemodynamic Monitoring System is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Icu Medical, Inc.. The 510(k) number is K152006.
When did Cogent Hemodynamic Monitoring System receive FDA 510(k) clearance?
Cogent Hemodynamic Monitoring System received FDA 510(k) clearance on 2016-05-05, under 510(k) number K152006.
Who is the listed applicant for Cogent Hemodynamic Monitoring System?
The FDA 510(k) record lists Icu Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cogent Hemodynamic Monitoring System?
The FDA product code for Cogent Hemodynamic Monitoring System is DXQ.
相關臨床試驗
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其他以 Icu Medical, Inc. 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：DXQ）
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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