統合泌尿學閉環導尿管
K 號：K160877 · 2016-05-20
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器材摘要
United Urologics Closed System Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Robling Medical, Inc.. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K160877. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the United Urologics Closed System Catheter?
United Urologics Closed System Catheter is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Robling Medical, Inc.. The 510(k) number is K160877.
When did United Urologics Closed System Catheter receive FDA 510(k) clearance?
United Urologics Closed System Catheter received FDA 510(k) clearance on 2016-05-20, under 510(k) number K160877.
Who is the listed applicant for United Urologics Closed System Catheter?
The FDA 510(k) record lists Robling Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for United Urologics Closed System Catheter?
The FDA product code for United Urologics Closed System Catheter is KOD.
相關臨床試驗
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相關器械（代碼：KOD）
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。
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