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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 K214077
Device Name Digital Thermometer, Model: DT007, DT008
Applicant
Guangzhou Berrcom Medical Device Co., Ltd.
#38 Huanzhen Xi Rd., Dagang Town, Nansha
Guangzhou,  CN 511470
Applicant Contact Zhigang Du
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, Block A, Zhongguan Times Square, Liuxian
Ave. Xili Town
Shenzhen,  CN 518000
Correspondent Contact Liz Li
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/27/2021
Decision Date 01/20/2023
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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