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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 K200781
Device Name Infrared Body Thermometer
Applicant
HeiTaiDa Technology Co., Ltd.
4F, BaiShiDa High-Tech Park, XiangDong Industrial Area
DaLingShan Town
DongGuan City,  CN 523820
Applicant Contact Tom Chen
Correspondent
Qimmiq Medical Consulting Service Co., Ltd
RM. 1711, Building K, NO. 101 Science Ave
International Creative Valley
Guangzhou,  CN 510663
Correspondent Contact You Yijie
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/11/2020
Decision Date 12/09/2020
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
Predetermined Change
Control Plan Authorized		 No
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