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)
CERVICAL-LUMBAR TRACTION SYSTEM "EVER PROSPEROUS" CERVICAL-LUMBAR TRACTION SYSTEM "EVER PROSPEROUS" “丹托林”牙科染色材 華宇藥品 華宇藥 新聞 CL66 清潔液 "成春" 一般手術用手動式器械 (未滅菌) 診斷型X光線裝置及其球管 快速 革蘭氏染色 踝關節固定術
Ever Prosperous Instruments | 合法醫療器材資訊網
Cervical-Lumbar Traction System. Model : Digit-Trac 930. 產品簡述. 衛署醫器製字第000877號 "Ever Prosperous" Cervical-Lumbar Traction System. Facebook ... Read More
電動頸腰牽引機CERVICAL | 合法醫療器材資訊網
電動頸腰牽引機CERVICAL-LUMBAR TRACTION SYSTEM "EVER PROSPEROUS" / 詳如中文仿單核定本。DIGIT-TRAC 930、ACCUTRAC。AUTO TRAC ... Read More
聯興儀器股份有限公司相關藥物 | 合法醫療器材資訊網
LOW FREQUENCY STIMULATOR "EVER PROSPEROUS" ... "DYNATRON" COMBINATION NEUROMUSCULAR STIMULATION AND ULTRASOUND DEVICE ... “REDCORD” nonpowered orthopedic traction apparatus and accessories (Non-Sterile) ... CERVICAL-LUMBAR TRACTION SYS Read More
電動頸腰牽引機 | 合法醫療器材資訊網
英文品名, CERVICAL-LUMBAR TRACTION SYSTEM "EVER PROSPEROUS". 效能 ... 增加規格:DYNATRON 900+、SM12 TRACTION、DIGIT-TRAC 930+。 Read More
ID No. 1419033869 | 合法醫療器材資訊網
Certification Information about Ever Prosperous Instrument Inc. / Medical Instrument, Cervical-Lumbar Traction System, DIGIT-TRAC 930. Read More
Traction System | 合法醫療器材資訊網
Ever prosperous Cervical-Lumbar Traction SystemAuthorized number: Department of Health No. 000877Model: DIGIT-TRAC 930*F | IMB2B.com. Read More
醫療器材許可證資料集 | 合法醫療器材資訊網
510(k) Premarket Notification | 合法醫療器材資訊網
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【電動頸腰牽引機】許可證字號:衛署醫器製字第000877號
器材品名:電動頸腰牽引機許可證字號:衛署醫器製字第000877號註銷狀態:註銷日期:註銷理由:有效日期:2025/10/31發證日期:2000/...