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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 K211583
Device Name Infrared Thermometer, Model: HW-1
Applicant
Dongguan Simzo Electronic Technology Co., Ltd.
# 6 Zhangzhou Rd., Daojiao Town
Dongguan City,  CN 523187
Applicant Contact Jinlong Wang
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.,
Rm. 1813#, Gebu Commercial Bldg., Hongxing Community,
Songgang St.
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/24/2021
Decision Date 09/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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