Infrared Thermometer (Model K9)

Thermometer, Electronic, Clinical

Kangzhan Communication Electronics Co., Ltd.

The following data is part of a premarket notification filed by Kangzhan Communication Electronics Co., Ltd. with the FDA for Infrared Thermometer (model K9).

Pre-market Notification Details

Device IDK203497
510k NumberK203497
Device Name:Infrared Thermometer (Model K9)
ClassificationThermometer, Electronic, Clinical
Applicant Kangzhan Communication Electronics Co., Ltd. No. 1008, Songbai Road, Yangguang Community, Xili Street, Nanshan District Shenzhen,  CN 518055
ContactSu Baotong
CorrespondentSu Baotong
Kangzhan Communication Electronics Co., Ltd. No. 1008, Songbai Road, Yangguang Community, Xili Street, Nanshan District Shenzhen,  CN 518055
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-27
Decision Date2021-10-08

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