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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 K181215
Device Name Infrared Thermometer
Applicant
Shenzhen Finicare Co., Ltd.
Room201, A Building NO. 1 Qianwan Road
Shengang Cooperative Zone, Qianhai
shenzhen,  CN 518052
Applicant Contact chao li
Correspondent
Shenzhen Finicare Co., Ltd.
Room201, A Building NO. 1 Qianwan Road
Shengang Cooperative Zone, Qianhai
shenzhen,  CN 518052
Correspondent Contact chao li
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/07/2018
Decision Date 01/02/2019
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
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