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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 K203454
Device Name Infrared Thermometer
Applicant
Shandong Zhushi Pharmaceutical Group Co., Ltd.
#6 Shande Rd., Shan Country
Heze,  CN 274300
Applicant Contact Junhui Zhu
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 Received11/23/2020
Decision Date 04/29/2021
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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