HEALTH CARE SYSTEM SOFTWARE

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 Health Care System Software.

Pre-market Notification Details

Device IDK110948
510k NumberK110948
Device Name:HEALTH CARE SYSTEM SOFTWARE
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP New Taipei County,  TW 24888
ContactTeling Hsu
CorrespondentTeling Hsu
TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP New Taipei County,  TW 24888
Product CodeNBW  
Subsequent Product CodeDXN
Subsequent Product CodeFLL
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-04
Decision Date2011-05-13
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.