REVOLUTION TD-4229 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 Revolution Td-4229 Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK072489
510k NumberK072489
Device Name:REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei,  TW 241
ContactErica Li
CorrespondentErica Li
TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei,  TW 241
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-04
Decision Date2007-09-20

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