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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 K182667
Device Name Med-link Temperature Probes
Applicant
Shenzhen Med-Link Electronics Tech Co., Ltd.
4th Floor, Bldg. A, Yingtailong Industrial Park
Dalang S. Rd., Longhua District
Shenzhen,  CN 518109
Applicant Contact Baihan Feng
Correspondent
Shenzhen Med-Link Electronics Tech Co., Ltd.
4th Floor, Bldg. A, Yingtailong Industrial Park
Dalang S. Rd., Longhua District
Shenzhen,  CN 518109
Correspondent Contact Baihan Feng
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/25/2018
Decision Date 06/18/2019
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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