快速壓力調節袋（RBB）泵及心臟內导管
K 號：K160287 · 2017-03-14
廣告
器材摘要
Rapid Barostat Bag (RBB) Pump and Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Mui Scientific. It received FDA 510(k) clearance on 2017-03-14 under 510(k) number K160287. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Rapid Barostat Bag (RBB) Pump and Catheter?
Rapid Barostat Bag (RBB) Pump and Catheter is a medical device that received FDA 510(k) clearance on 2017-03-14. The listed applicant is Mui Scientific. The 510(k) number is K160287.
When did Rapid Barostat Bag (RBB) Pump and Catheter receive FDA 510(k) clearance?
Rapid Barostat Bag (RBB) Pump and Catheter received FDA 510(k) clearance on 2017-03-14, under 510(k) number K160287.
Who is the listed applicant for Rapid Barostat Bag (RBB) Pump and Catheter?
The FDA 510(k) record lists Mui Scientific as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rapid Barostat Bag (RBB) Pump and Catheter?
The FDA product code for Rapid Barostat Bag (RBB) Pump and Catheter is FFX.
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：FFX）
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