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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 K190189
Device Name MDT2 BLE Self-Monitoring Blood Glucose System
Applicant
Eps Bio Technology Corp.
# 8 R&D Rd.Iii, Hsinchu Science Park
Hsinchu,  TW 30077
Applicant Contact Cynthia Hung
Correspondent
Eps Bio Technology Corp.
# 8 R&D Rd.Iii, Hsinchu Science Park
Hsinchu,  TW 30077
Correspondent Contact RF Jain
Regulation Number862.1345
Classification Product Code
NBW  
Date Received02/01/2019
Decision Date 11/01/2019
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
Predetermined Change
Control Plan Authorized		 No
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