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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 K201579
Device Name Infrared Thermometer
Applicant
Shenzhen Xunwei Industrial Co., Ltd.
First Floor To Fourth, Upper Small Industrial Zone,
Jinhua Rd., Block 75, Xixiang
Shenzhen,  CN 518102
Applicant Contact Liu Shengcai
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, Block A, Zhongguan Times Square, Liuxian
Ave. Xili Town
Shenzhen,  CN 518000
Correspondent Contact Yoyo Chen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/11/2020
Decision Date 01/15/2021
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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