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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 K202296
Device Name Infrared Forehead Thermometer, Model BSX976
Applicant
Shenzhen Bsx Technology Electronics Co., Ltd.
Rm301.3f 8th Bldg., Lihao Industrial Area,
#78 Ainan Rd.
Shenzhen,  CN 518116
Applicant Contact Lijuan Du
Correspondent
Shenzhen Bsx Technology Electronics Co., Ltd.
Rm301.3f 8th Bldg., Lihao Industrial Area,
#78 Ainan Rd.
Shenzhen,  CN 518116
Correspondent Contact Lijuan Du
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/13/2020
Decision Date 07/23/2021
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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