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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 K223044
Device Name Digital Thermometer (Model QT001)
Applicant
Shen Zhen Rong Feng Technology Co., Ltd.
3/F R Bldg. Shasi Industrial Park, Shajing Town
Baoan District
Shenzhen,  CN
Applicant Contact Hong Xiao Lan
Correspondent
Shen Zhen Rong Feng Technology Co., Ltd.
3/F R Bldg. Shasi Industrial Park, Shajing Town
Baoan District
Shenzhen,  CN
Correspondent Contact Jett Lee
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/29/2022
Decision Date 05/10/2023
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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