Non-contact Forehead Thermometer

Thermometer, Electronic, Clinical

Shenzhen Dongdixin Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co., Ltd. with the FDA for Non-contact Forehead Thermometer.

Pre-market Notification Details

Device IDK161735
510k NumberK161735
Device Name:Non-contact Forehead Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Shenzhen Dongdixin Technology Co., Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen,  CN 518108
ContactSiping Yuan
CorrespondentSiping Yuan
Shenzhen Dongdixin Technology Co., Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen,  CN 518108
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-23
Decision Date2016-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816479015601 K161735 000
06926408700165 K161735 000
16926408700209 K161735 000
06926408700455 K161735 000
20311917221384 K161735 000
10891040701173 K161735 000
20311917047212 K161735 000

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