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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 K232678
Device Name Digital Thermometer, Model T28, T28L
Applicant
Guangdong Genial Technology Co., Ltd.
I-6-05-02, 11th Rd., Area B, Guangfozhao Economic
Cooperation Zone, Zhagang Town, Huaiji Co
Zhaoqing,  CN 526437
Applicant Contact Yu Jun
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.Ltd
Rm. 1407, Jingting Bldg., Dongzhou Community
Guangming St., Guangming District
Shenzhen,  CN 518107
Correspondent Contact Reanny Wang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/01/2023
Decision Date 01/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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