Infrared Body Thermometer

Thermometer, Electronic, Clinical

HeTaiDa Technology Co., Ltd.

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

Pre-market Notification Details

Device IDK180385
510k NumberK180385
Device Name:Infrared Body Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant HeTaiDa 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 Received2018-02-12
Decision Date2018-05-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16970289030009 K180385 000
16970289035042 K180385 000
16970289035271 K180385 000
16970289035264 K180385 000
16970289035301 K180385 000
16970289035318 K180385 000
16970289035455 K180385 000
16970289035462 K180385 000
16970289035660 K180385 000

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