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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 K203583
Device Name YUWELL infrared ear thermometer: YHT101, YHT200
Applicant
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
Yunyang Industrial Park, Danyang, Jiangsu, China
Jiangsu,  CN 212300
Applicant Contact Yuzhuo Wang
Correspondent
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
Yunyang Industrial Park, Danyang, Jiangsu, China
Jiangsu,  CN 212300
Correspondent Contact Yuzhuo Wang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/08/2020
Decision Date 05/20/2021
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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