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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K190984
Device Name Infrared Forehead Thermometer
Applicant
Xiamen Ants Bro Technology Co., Ltd.
4th & 5th Floor, No.5 Building, Tech & Innovation Center
No. 289 Wengjiao Road, Haicang District
Xiamen,  CN 361026
Applicant Contact Jane Xu
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Building 1, Rui Feng Center, Kaichuang Road
Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/15/2019
Decision Date 04/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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