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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK123935
Test Name Andon Health Co., LTD. iHealth Wireless Smart Gluco-Monitoring System (BG5)  
Manufacturer NameAndon Medical Co., Ltd.
Consumer Information Phone Number(855)816-7705
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date09/15/2016
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K123935
FOIA Releasable 510(k) K123935
Device Name IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
Applicant
Andon Medical Co., Ltd.
#26 Hangyu Rd.
Tianjin Airport Economic Area
Tianjin,  CN 300381
Applicant Contact YI LIU
Correspondent
Andon Medical Co., Ltd.
#26 Hangyu Rd.
Tianjin Airport Economic Area
Tianjin,  CN 300381
Correspondent Contact YI LIU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX   JQP  
Date Received12/20/2012
Decision Date 04/12/2013
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
Predetermined Change
Control Plan Authorized		 No
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