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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 K191668
Device Name Infrared Forehead Thermometer (Model IR-FT)
Applicant
Comper Chuangxiang (Beijing) Technology Co., Ltd.
Room 102-103 1st Floor, Building 4 No. 1 Kangding Street
daxing district,  CN 100176
Applicant Contact han du
Correspondent
Comper Chuangxiang (Beijing) Technology Co., Ltd.
Room 102-103 1st Floor, Building 4 No. 1 Kangding Street
daxing district,  CN 100176
Correspondent Contact han du
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/21/2019
Decision Date 10/18/2019
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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