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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K122181
Device Name EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
VISGENEER, INC.
no. 188, sec. 3
gongdao 5th road
hsinchu city,  TW 30069
Original Contact jack yang
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received07/23/2012
Decision Date 08/15/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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