CLEVER CHOICE VOICE+ 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 Clever Choice Voice+ Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK102049
510k NumberK102049
Device Name:CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU TOWNSHIP Taipei County,  TW 24888
ContactTeling Hsu
CorrespondentTeling Hsu
TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU TOWNSHIP Taipei County,  TW 24888
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-21
Decision Date2011-05-27
Summary:summary

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