FORA V20 BLOOD GLUCOSE MONITORING SYSTEM

Glucose Oxidase, Glucose

TaiDoc Technology Corporation

The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora V20 Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK100406
510k NumberK100406
Device Name:FORA V20 BLOOD GLUCOSE MONITORING SYSTEM
ClassificationGlucose Oxidase, Glucose
Applicant TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD. WUGU TOWNSHIP Taipei County,  TW 24888
ContactNicky Pan
CorrespondentNicky Pan
TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD. WUGU TOWNSHIP Taipei County,  TW 24888
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-16
Decision Date2010-05-11
Summary:summary

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