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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 K201508
Device Name Infrared Thermometer
Applicant
Dongguan Prestige Sporting Goods Co., Ltd.
3rd Industrial, Qiaotou Area, Houjie Town
Dongguan,  CN 518118
Applicant Contact Zhang Zhao
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd., Huangpu
District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/05/2020
Decision Date 03/09/2021
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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