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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 K200471
Device Name Infrared Thermometer Model Number RN-60A,RN-60B
Applicant
Ningbo Ranor Medical Science & Technology Co., Ltd.
# 127 Fenghui Rd., Wangchun Industrial Park,
Haishu District
Ningbo,  CN 315000
Applicant Contact Emma Hu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.608,# 738,Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/26/2020
Decision Date 06/19/2020
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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