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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 K182057
Device Name EasyMax BT Self-Monitoring Blood Glucose System
Applicant
EPS Bio Technology Corp.
No. 8, R&D RD III
Hsinchu Science Park
Hsinchu,  TW 30077
Applicant Contact Cynthia Hung
Correspondent
EPS Bio Technology Corp.
No. 8, R&D RD III
Hsinchu Science Park
Hsinchu,  TW 30077
Correspondent Contact Cynthia Hung
Regulation Number862.1345
Classification Product Code
NBW  
Date Received07/31/2018
Decision Date 08/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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