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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 K162083
Device Name RII Multi-function Infrared Thermometer, Model TH52Z
Applicant
Radiant Innovation Inc.
1F, No.3 Industrial E. 9th Rd.
Science-Based, Industrial Park
HsinChu,  TW 30075
Applicant Contact Monica Chung
Correspondent
Radiant Innovation Inc.
1F, No.3 Industrial E. 9th Rd.
Science-Based, Industrial Park
HsinChu,  TW 30075
Correspondent Contact Monica Chung
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/27/2016
Decision Date 01/09/2017
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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