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.
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References Learn more... (www.fda.gov)
"ALTHIN" HEMODIALYSIS DELIVERY SYSTEM "ALTHIN" HEMODIALYSIS DELIVERY SYSTEM 自費比價網 開元 骨科 掛號 茂隆骨科 網 路 掛號 前瞻儀器股份有限公司 可吸收 骨 釘 材質 骨折拆鋼釘復原時間 超廣角眼底攝影 眼 超 音波
510(k) Premarket Notification | 合法醫療器材資訊網
510(k) Premarket Notification | 合法醫療器材資訊網
510(k) Premarket Notification | 合法醫療器材資訊網
510(k) Premarket Notification | 合法醫療器材資訊網
K954987.pdf | 合法醫療器材資訊網
血液透析機"ALTHIN" HEMODIALYSIS DELIVERY SYSTEM ... | 合法醫療器材資訊網
血液透析機"ALTHIN" HEMODIALYSIS DELIVERY SYSTEM} | 合法醫療器材資訊網
血液透析機"ALTHIN" HEMODIALYSIS DELIVERY SYSTEM} | 合法醫療器材資訊網
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【血液透析機】許可證字號:衛署醫器輸字第007040號
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