確保性
K 號：K181269 · 2018-12-14
廣告
器材摘要
iCertainty is the device name listed in this FDA 510(k) record. The listed applicant is Rfpi. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K181269. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the iCertainty?
iCertainty is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Rfpi. The 510(k) number is K181269.
When did iCertainty receive FDA 510(k) clearance?
iCertainty received FDA 510(k) clearance on 2018-12-14, under 510(k) number K181269.
Who is the listed applicant for iCertainty?
The FDA 510(k) record lists Rfpi as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iCertainty?
The FDA product code for iCertainty is DPW.
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：DPW）
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。
K260700藍多普血管專家BlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek 套件、VascuChek 轨射器、VascuChek 醫學探針、VascuChek 聲音基座（VC-KIT-02、VC-TRX-02、VC-CP-01、VC-SD-01）；VascuChek 套件、VascuChek 轨射器、VascuChek 外科探針、VascuChek 聲音基座（VC-KIT-02、VC-TRX-02、VC-SP-01、VC-SD-01）Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek 套件、VascuChek 訊號傳送器、VascuChek 醫學探針、VascuChek 充電器（VC-KIT-01、VC-TRX-01、VC-CP-01、VC-CH-01）；VascuChek 套件、VascuChek 訊號傳送器、VascuChek 外科探針、VascuChek 充電器（VC-KIT-01、VC-TRX-01、VC-SP-01、VC-CH-01）Remington Medical, Inc.
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