Digital Thermometer Model T103, T104

Thermometer, Electronic, Clinical

Bioland Technology Ltd.

The following data is part of a premarket notification filed by Bioland Technology Ltd. with the FDA for Digital Thermometer Model T103, T104.

Pre-market Notification Details

Device IDK201879
510k NumberK201879
Device Name:Digital Thermometer Model T103, T104
ClassificationThermometer, Electronic, Clinical
Applicant Bioland Technology Ltd. No. A6B7 (Block G) ShangRong Industrial Zone No. 5 Baolong R Shenzhen,  CN 518116
ContactYiqing Feng
CorrespondentYiqing Feng
Bioland Technology Ltd. No. A6B7 (Block G) ShangRong Industrial Zone No. 5 Baolong R Shenzhen,  CN 518116
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-07
Decision Date2021-03-31

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