Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503

Thermometer, Electronic, Clinical

Shenzhen Changkun Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Changkun Technology Co., Ltd. with the FDA for Infrared Thermometer, Model Number Ck-t1501, Ck-t1502, Ck-t1503.

Pre-market Notification Details

Device IDK193253
510k NumberK193253
Device Name:Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
ClassificationThermometer, Electronic, Clinical
Applicant Shenzhen Changkun Technology Co., Ltd. 801, 3F, B Building, NO. 69, Zhenbi Road Biling Community, Pingshan District Shenzhen,  CN 518118
ContactSteve Li
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou,  CN 510000
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-18
Decision Date2020-06-17

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