Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711

Thermometer, Electronic, Clinical

Alicn Medical Shenzhen,Inc

The following data is part of a premarket notification filed by Alicn Medical Shenzhen,inc with the FDA for Infrared Thermometer, Model: Aet-r1b1, Aet-r161, Aet-r171, Aet-r1d1, Aet-r1d2, Aet-r1f1, Aet-r701, Aet-r711.

Pre-market Notification Details

Device IDK210565
510k NumberK210565
Device Name:Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711
ClassificationThermometer, Electronic, Clinical
Applicant Alicn Medical Shenzhen,Inc Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, Kengzi Shenzhen,  CN 518118
ContactFang Meisong
CorrespondentFang Meisong
Alicn Medical Shenzhen,Inc Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, Kengzi Shenzhen,  CN 518118
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-25
Decision Date2022-05-05

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