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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 K201536
Device Name Infrared Forehead Thermometer
Applicant
Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.
#688 Dong'An 1st Rd., Xintang St., Xaioshan District
Hangzhou,  CN 311200
Applicant Contact Jenny Li
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, Block A, Zhongguan Times Sq., Liuxian
Ave. Xili Town
Shenzhen,  CN 518000
Correspondent Contact Yoyo Chen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/08/2020
Decision Date 02/10/2021
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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