茲里希壓力導絲系統型號100
K 號：K190852 · 2019-08-14
廣告
器材摘要
Zurich Pressure Guidewire System Model 100 is the device name listed in this FDA 510(k) record. The listed applicant is Zurich Medical, Inc.. It received FDA 510(k) clearance on 2019-08-14 under 510(k) number K190852. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Zurich Pressure Guidewire System Model 100?
Zurich Pressure Guidewire System Model 100 is a medical device that received FDA 510(k) clearance on 2019-08-14. The listed applicant is Zurich Medical, Inc.. The 510(k) number is K190852.
When did Zurich Pressure Guidewire System Model 100 receive FDA 510(k) clearance?
Zurich Pressure Guidewire System Model 100 received FDA 510(k) clearance on 2019-08-14, under 510(k) number K190852.
Who is the listed applicant for Zurich Pressure Guidewire System Model 100?
The FDA 510(k) record lists Zurich Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zurich Pressure Guidewire System Model 100?
The FDA product code for Zurich Pressure Guidewire System Model 100 is DXO.
相關臨床試驗
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：DXO）
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。
廣告