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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 K181215
Device Name Infrared Thermometer
Applicant
Shenzhen Finicare Co., Ltd.
Rm.201, A Bldg. # 1 Qianwan Rd.
Shengang Cooperative Zone, Qianhai
Shenzhen,  CN 518052
Applicant Contact Chao Li
Correspondent
Shenzhen Finicare Co., Ltd.
Rm.201, A Bldg. # 1 Qianwan Rd.
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
Predetermined Change
Control Plan Authorized		 No
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