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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K213038
Device Name Infrared Forehead Thermometer, model: HS-9802D
Applicant
Jiaxing Shangjia Intelligence Technology Co., Ltd.
Rm. 102 & 202, Bldg. # 9,
Jiaxing Intelligence & Innovation Park, # 36
Jiaxing,  CN 314000
Applicant Contact Lou Yongwei
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
Rm.1711, Bldg. K, #101 Science Ave.
International Creative Valley
Guangzhou,  CN 510663
Correspondent Contact You Yijie
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/21/2021
Decision Date 03/10/2022
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
Predetermined Change
Control Plan Authorized		 No
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