Infrared Ear 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 Ear Thermometer.

Pre-market Notification Details

Device IDK180387
510k NumberK180387
Device Name:Infrared Ear Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant HeTaiDa Technology Co., Ltd. 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area DaLingShan Town Foshan 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 Date2019-01-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16970289030061 K180387 000
40504280825158 K180387 000

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