510(k) Premarket Notification | 合法醫療器材資訊網
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
Learn more...[1]
References Learn more... (www.fda.gov)
"TRAVENOL" PERITONEAL DIALYSIS SETS "TRAVENOL" PERITONEAL DIALYSIS SETS “理音”聽阻檢查儀及其配件 easytech reverse shoulder system “Sagemax” NexxZr Coloring Liquids “Dufner”Plastic surgery kit and accessories (Non-Sterile) 藥廠 微生物 檢驗 3-二氨基聯苯胺鹽酸鹽免疫組織化學染色套組 裝心律調節器存活率 新型心律調節器
510(k) Premarket Notification | 合法醫療器材資訊網
Double bag or Y‐set versus standard transfer systems for ... | 合法醫療器材資訊網
EP2280746A1 | 合法醫療器材資訊網
EP2398528B1 | 合法醫療器材資訊網
Reduced risk for peritonitis in CAPD with the use of a UV ... | 合法醫療器材資訊網
US5053003A | 合法醫療器材資訊網
US8636706B2 | 合法醫療器材資訊網
腹膜透析套. "TRAVENOL" PERITONEAL DIALYSIS SETS} | 合法醫療器材資訊網
相關資訊整理
【腹膜透析套.】許可證字號:衛署醫器輸字第003401號
器材品名:腹膜透析套.許可證字號:衛署醫器輸字第003401號註銷狀態:已註銷註銷日期:1991/07/23註銷理由:中文品名變更;;英文...