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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 K180207
Device Name Non-contact Infrared Thermometer
Applicant
Alicn Medical (Shenzhen), Inc
4/F, B Building, Shenfubao Modern Optical Factory
Kengzi Street, Pingshan Dist
Shezhen,  CN 518122
Applicant Contact Meisong Fang
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co, Lt
Room 2012 of Gebu commercial building, Hongxing, Songgang
Baoan District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/24/2018
Decision Date 11/28/2018
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
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