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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 K171888
Device Name Non-contact infrared body thermometer
Applicant
Hetaida Technology Co., Ltd.
4f, Baishida High-Tech Park, Xiandong Industrial Area,
Dalingshan
Dongguan,  CN 523820
Applicant Contact ZhenGuang Chen
Correspondent
Elliiot Medical Solutions
18586 Parkland Dr.
Shaker Heights,  OH  44122
Correspondent Contact Roman Huang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/26/2017
Decision Date 07/23/2018
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
Predetermined Change
Control Plan Authorized		 No
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