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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK160365
Test Name Entra Health BLE Smart Professional Blood Glucose Monitoring System  
Manufacturer NameInfopia Co, Ltd.
Consumer Information Phone Number877-458 Ext.2646
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date09/29/2018
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K160365
Device Name BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System
Applicant
Infopia Co, Ltd.
132, Anyangcheondong-Ro, Dongan-Gu
Anyang,  KR 14040
Applicant Contact NA YUN KIM
Correspondent
LK Consulting Group USA, Inc.
800 Roosevelt
Suite 417
Irvine,  CA  92620
Correspondent Contact PRISCILLA CHUNG
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received02/09/2016
Decision Date 09/28/2016
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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