NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254

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 No-coding Blood Glucose Monitoring System, Models Td-4251, Td-4252, Td-4253 And Td-4254.

Pre-market Notification Details

Device IDK092099
510k NumberK092099
Device Name:NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County,  TW 248
ContactDebra Liang
CorrespondentDebra Liang
TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County,  TW 248
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-14
Decision Date2009-12-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
80816042013917 K092099 000

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