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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK152534
Test Name Tianjin Empecs Medical Device Co., Ltd. Medisign MM 1100 BT MULTI Blood Glucose Monitoring System  
Manufacturer NameTIANJIN EMPECS MEDICAL DEVICE CO., LTD.
Consumer Information Phone Number1(888)885-6677
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date04/04/2017
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K152534
Device Name Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI
Applicant
TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
NO.35 AND 37, YINGCHENG STREET
HANGU,  CN 300480
Applicant Contact CHAE CHUNG LYUEL
Correspondent
MDI CONSULTANTS, INC.
55 NORTHERN BLVD., SUITE 200
GREAT NECK,  NY  11021
Correspondent Contact JIGAR SHAH
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received09/04/2015
Decision Date 03/21/2017
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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