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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 K182755
Device Name Disposable Temperature Probe
Applicant
Shenzhen Caremed Medical Technology Co., Ltd.
East Side, 3/F, C Bldg., Kelunte Low-Carbon Industries
Gaofeng Community
Dalang Office, Longhua District, Shenzhe,  CN 518109
Applicant Contact Alan Xie
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
# A415, Block A, Nanshan Medical Devices Industrial Park
Nanshan District,
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/28/2018
Decision Date 12/21/2018
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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