FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E

Thermometer, Electronic, Clinical

TaiDoc Technology Corporation

The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Ir20b Ear Thermometer, Model Td-1261f, Fora Ir21b Ear Thermometer, Model Td-1261e.

Pre-market Notification Details

Device IDK090395
510k NumberK090395
Device Name:FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E
ClassificationThermometer, Electronic, Clinical
Applicant TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County,  TW 241
ContactYuhua Chen
CorrespondentYuhua Chen
TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County,  TW 241
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-17
Decision Date2009-03-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816042013430 K090395 000
00816042012181 K090395 000
80816042011814 K090395 000
00816042014710 K090395 000
00816042013928 K090395 000
00816042014024 K090395 000
00816042011276 K090395 000
00816042011726 K090395 000
00816042012198 K090395 000
80816042011098 K090395 000

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