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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K182133
Device Name Infrared Thermometer
Applicant
Shenzhen AOJ Medical Technology Co., Ltd.
Room 202, HaoGu Industry Park, 2037 Guanguang road,
Guangming district
Shenzhen,  CN 518103
Applicant Contact Qihuan Zhao
Correspondent
Shenzhen AOJ Medical Technology Co., Ltd.
Room 202, HaoGu Industry Park, 2037 Guanguang road,
Guangming district
Shenzhen,  CN 518103
Correspondent Contact Qihuan Zhao
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/06/2018
Decision Date 11/20/2018
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
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