Infrared Body Thermometer

Thermometer, Electronic, Clinical

HeiTaiDa Technology Co., Ltd.

The following data is part of a premarket notification filed by Heitaida Technology Co., Ltd. with the FDA for Infrared Body Thermometer.

Pre-market Notification Details

Device IDK200781
510k NumberK200781
Device Name:Infrared Body Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant HeiTaiDa Technology Co., Ltd. 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area DaLingShan Town Dongguan City,  CN 523820
ContactTom Chen
CorrespondentYou Yijie
Qimmiq Medical Consulting Service Co., Ltd RM. 1711, Building K, NO. 101 Science Ave International Creative Valley Guangzhou,  CN 510663
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-11
Decision Date2020-12-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16970289035202 K200781 000
06970289035175 K200781 000
16970289035356 K200781 000
16970289035349 K200781 000
16970289035431 K200781 000

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