510(k) Premarket Notification | 合法醫療器材資訊網
CARDGUARDSCIENTIFICSURVIVAL,LTD.K10170318,07/13/2010.cg-6108act-ilcontinuousecgmonitorandarrythmiadetector19 ...
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)
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Card Guard Scientific Survival Ltd. CO Ms. Na'ama Oren QA ... | 合法醫療器材資訊網
2021年1月1日 — 12-lead ECG monitor using an'extemal patient cable. 2. Intended Use. The PMP4 SelfCheckTM and Card Guard Heart Screening Service are ... Read More
510(k) Premarket Notification | 合法醫療器材資訊網
Device Name, CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER. Applicant. CARD GUARD SCIENTIFIC SURVIVAL, LTD. 19636 CLUB ... Read More
510(k) Premarket Notification | 合法醫療器材資訊網
CARD GUARD SCIENTIFIC SURVIVAL, LTD. K10170318, 07/13/2010. cg-6108 act-il continuous ecg monitor and arrythmia detector19 ... Read More
510(k) Premarket Notification | 合法醫療器材資訊網
CARD GUARD SCIENTIFIC SURVIVAL, LTD. K92448622, 10/31/1994. card guard, model cg-7000d ecg recorder/transmitter23, CARD ... Read More
510(k) Premarket Notification | 合法醫療器材資訊網
2021年3月15日 — CARD GUARD SCIENTIFIC SURVIVAL, LTD. K99047828, 08/31/1999. card guard, model cg-7000d ecg recorder/transmitter29, CARD ... Read More
"卡佳德"心電圖計"CARD GUARD" ECG RECORDER} | 合法醫療器材資訊網
卡佳德心電圖計CARD GUARD ECG RECORDER / CG-2100,CG-7100,以下空白/ 藥要看提供簡單的介面檢索國內有註冊登記的藥品資訊. Read More
Card Guard | 合法醫療器材資訊網
A personal 1-lead ECG event recorder that stores up to 6 events in its ... 3 x 60 seconds of real-time ECG -optional. Caution: Federal ... Card Guard CG-2206. Read More
Card Guard AG | 合法醫療器材資訊網
ECG Monitor Extends its Leads to Three. Card Guard AG has introduced its next-generation LifeStar ACT III Platinum system with 3-lead ECG functionality,. Read More
Card Guard 12 Lead ECG CG | 合法醫療器材資訊網
CONTEC 3 /12-lead Holter ECG Monitor Machine Recorder Analyzer USB Sync Software. $299.00 ... thumbnail 1 - Card Guard 12 Lead ECG CG-7000D ... Read More
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