TheraView TBI
K 號：K170058 · 2017-03-03
廣告
器材摘要
TheraView TBI is the device name listed in this FDA 510(k) record. The listed applicant is Cablon Medical B.V.. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K170058. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TheraView TBI?
TheraView TBI is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Cablon Medical B.V.. The 510(k) number is K170058.
When did TheraView TBI receive FDA 510(k) clearance?
TheraView TBI received FDA 510(k) clearance on 2017-03-03, under 510(k) number K170058.
Who is the listed applicant for TheraView TBI?
The FDA 510(k) record lists Cablon Medical B.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TheraView TBI?
The FDA product code for TheraView TBI is IYE.
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：IYE）
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