OPTOVISION內視鏡光源單元
K 號：K243591 · 2025-02-19
廣告
器材摘要
OPTOVISION Endoscopic Light Source Unit is the device name listed in this FDA 510(k) record. The listed applicant is Optosurgical, LLC. It received FDA 510(k) clearance on 2025-02-19 under 510(k) number K243591. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OPTOVISION Endoscopic Light Source Unit?
OPTOVISION Endoscopic Light Source Unit is a medical device that received FDA 510(k) clearance on 2025-02-19. The listed applicant is Optosurgical, LLC. The 510(k) number is K243591.
When did OPTOVISION Endoscopic Light Source Unit receive FDA 510(k) clearance?
OPTOVISION Endoscopic Light Source Unit received FDA 510(k) clearance on 2025-02-19, under 510(k) number K243591.
Who is the listed applicant for OPTOVISION Endoscopic Light Source Unit?
The FDA 510(k) record lists Optosurgical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OPTOVISION Endoscopic Light Source Unit?
The FDA product code for OPTOVISION Endoscopic Light Source Unit is OWN.
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：OWN）
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。
K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KGK254180PerfusiX-影像LIMIS Development B.V.K242163智能手術視覺系統SmartsurgN, Inc.K254242KARL STORZ ICG影像系統搭配RUBINA®鏡頭Karl Storz SE & CO. KGK251852cCeLL - 適用於In vivo與Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K253972影像1 (TC400US)；X至4U轉接器 (TC040)Karl Storz SE & CO. KG
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