IHealth Infrared No-Touch Forehead Thermometer

Thermometer, Electronic, Clinical

Andon Health Co., Ltd.

The following data is part of a premarket notification filed by Andon Health Co., Ltd. with the FDA for Ihealth Infrared No-touch Forehead Thermometer.

Pre-market Notification Details

Device IDK200531
510k NumberK200531
Device Name:IHealth Infrared No-Touch Forehead Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Andon Health Co., Ltd. No. 3 Jin Ping Street,Ya An Road, Nankai District Tianjin,  CN 300190
ContactLiu Yi
CorrespondentLiu Yi
Andon Health Co., Ltd. No. 3 Jin Ping Street,Ya An Road, Nankai District Tianjin,  CN 300190
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-02
Decision Date2020-07-15

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