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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 K201843
Device Name Infrared ear and forehead thermometer, model YI-100
Applicant
Wenzhou Yosun Medical Technology Co.,Ltd
#17 ,Shahong Rd.,Lingmen Beibaixiang Town
Yueqing
Wenzhou,  CN 325603
Applicant Contact Lihao Yang
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Rm. 1813#, Gebu Commerical Bldg., Hongxing Community,
Songgang St.
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/06/2020
Decision Date 10/23/2020
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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