Non-contact 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 Non-contact Infrared Body Thermometer.

Pre-market Notification Details

Device IDK171888
510k NumberK171888
Device Name:Non-contact Infrared Body Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Hetaida Technology Co., Ltd 4F, BaiShiDa High-Tech Park, XianDong Industrial Area, DaLingShan Dongguan,  CN 523820
ContactZhenguang Chen
CorrespondentRoman Huang
Elliiot Medical Solutions 18586 Parkland Drive Shaker Heights,  OH  44122
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-26
Decision Date2018-07-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16970289030054 K171888 000
16970289030047 K171888 000
08719699630444 K171888 000
08719699630437 K171888 000
16970289030078 K171888 000
00817915020142 K171888 000
00634782899806 K171888 000
00634782899783 K171888 000

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