Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311

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 Electronic Thermometer, Model: Aet-e201, Aet-e211, Aet-e221, Aet-e231, Aet-e241, Aet-e251, Aet-e301, Aet-e311.

Pre-market Notification Details

Device IDK212257
510k NumberK212257
Device Name:Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311
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 Received2021-07-19
Decision Date2022-05-04

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