U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118

Thermometer, Electronic, Clinical

TaiDoc Technology Corporation

The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Ear Themometer, Models Td-1115 And Td-1118.

Pre-market Notification Details

Device IDK100942
510k NumberK100942
Device Name:U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118
ClassificationThermometer, Electronic, Clinical
Applicant TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD. WUGU TOWNSHIP Taipei County,  TW 24888
ContactNicky Pan
CorrespondentNicky Pan
TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD. WUGU TOWNSHIP Taipei County,  TW 24888
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-04-05
Decision Date2010-05-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816042012228 K100942 000
80816042012231 K100942 000

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