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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K193625
Device Name Disposable Temperature Probe
Applicant
Shenzhen Changke Connect Electronics Co., Ltd.
A2-4th floor of Xiang dali Technology Park
No.87 of HengPing Road, Henggang, Longgang District
Shenzhen,  CN 518000
Applicant Contact Yahui Zhou
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
No. 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 Received12/26/2019
Decision Date 07/24/2020
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
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