FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE 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 Fora D40 Blood Glucose Plus Blood Pressure Monitoring System.

Pre-market Notification Details

Device IDK101926
510k NumberK101926
Device Name:FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE 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
ContactLinda Ko
CorrespondentLinda Ko
TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD. WUGU TOWNSHIP Taipei County,  TW 24888
Product CodeNBW  
Subsequent Product CodeCGA
Subsequent Product CodeDXN
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-09
Decision Date2011-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816042013447 K101926 000
00816042011771 K101926 000
00816042013959 K101926 000
00850001002011 K101926 000
00816042011009 K101926 000
00816042012044 K101926 000
00816042012846 K101926 000
00816042012853 K101926 000
00816042013256 K101926 000
00816042014628 K101926 000

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