Infrared Thermometer

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.

Pre-market Notification Details

Device IDK210564
510k NumberK210564
Device Name:Infrared Thermometer
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 Date2022-01-07

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