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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K201864
Device Name YUWELL Infrared Thermometer
Applicant
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Yunyang Industrial Park, Danyang, Jiangsu, China
Danyang,  CN 212300
Applicant Contact Caixia Yang
Correspondent
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Yunyang Industrial Park, Danyang, Jiangsu, China
Danyang,  CN 212300
Correspondent Contact Caixia Yang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/06/2020
Decision Date 12/07/2020
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
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