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Document NumberK081714
Test Name Fora Care Inc. FORA TD-3224 Blood Glucose Plus Blood Pressure Monitoring System  
Manufacturer NameTaidoc Technology Corporation
Consumer Information Phone Number1(805)230-3068
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date07/30/2008
Device Classification Name Glucose Oxidase, Glucose
510(k) Number K081714
Device Name FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
Applicant
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
New Taipei City,  TW 248
Applicant Contact Yuhua Chen
Correspondent
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
New Taipei City,  TW 248
Correspondent Contact Yuhua Chen
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
DXN   NBW  
Date Received06/18/2008
Decision Date 07/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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