FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE

Glucose Oxidase, Glucose

TaiDoc Technology Corporation

The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora D20 Blood Glucose Plus Blood Pressure Monitoring System; Td-3263 Blood Glucose Plus Blood Pressure Monitoring Syste.

Pre-market Notification Details

Device IDK091814
510k NumberK091814
Device Name:FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE
ClassificationGlucose Oxidase, Glucose
Applicant TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County,  TW 24888
ContactErica Li
CorrespondentErica Li
TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County,  TW 24888
Product CodeCGA  
Subsequent Product CodeDXN
Subsequent Product CodeNBW
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-18
Decision Date2009-11-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816042010200 K091814 000

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