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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 K213079
Device Name Ear Thermometer, Model ET001
Applicant
Guangzhou Berrcom Medical Device Co., Ltd.
#38 Huanzhen Xi Rd., Dagang Town, Nansha
Guangzhou,  CN 51147
Applicant Contact Zhigang Du
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Square
Liuxian Ave., Xili Town, Nanshan District,
Shenzhen,  CN 518000
Correspondent Contact Yoyo Chen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/23/2021
Decision Date 02/18/2022
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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