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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 K202741
Device Name Infrared Forehead Thermometer
Applicant
Shenzhen Combei Technology Co., Ltd.
# 105, Huanguan S. Rd., Dahe Community, Guanlan, Long
Hua New Distri
Shenzhen,  CN 518110
Applicant Contact Kevin Fong
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, Block A, Zhongguan Times Sq., Liuxian
Ave. Xili Town
Shenzhen,  CN 518000
Correspondent Contact Yoyo Chen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/18/2020
Decision Date 07/07/2021
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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