IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM

System, Test, Blood Glucose, Over The Counter

TaiDoc Technology Corporation

The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Ideal Life Gluco-manager Gmm 0001 Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK080283
510k NumberK080283
Device Name:IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County,  TW 248
ContactYuhua Chen
CorrespondentYuhua Chen
TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County,  TW 248
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-04
Decision Date2008-06-27
Summary:summary

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