OptumSI 嵌入式系統
K 號：K251365 · 2025-11-20
廣告
器材摘要
OptumSI Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Si Solutions, LLC. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K251365. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OptumSI Implant System?
OptumSI Implant System is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Si Solutions, LLC. The 510(k) number is K251365.
When did OptumSI Implant System receive FDA 510(k) clearance?
OptumSI Implant System received FDA 510(k) clearance on 2025-11-20, under 510(k) number K251365.
Who is the listed applicant for OptumSI Implant System?
The FDA 510(k) record lists Si Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OptumSI Implant System?
The FDA product code for OptumSI Implant System is OUR.
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：OUR）
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