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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 K191283
Device Name Infrared Thermometer, Breeze model
Applicant
Suzhou Melodicare Medical Technology Co.,Ltd.
Building Room 301, No 32 Hongxi Road, Suzhou High-Tech Zone
suzhou,  CN 215163
Applicant Contact xiaoqian zou
Correspondent
Suzhou Melodicare Medical Technology Co.,Ltd.
Building Room 301, No 32 Hongxi Road, Suzhou High-Tech Zone
suzhou,  CN 215163
Correspondent Contact xiaoqian zou
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/13/2019
Decision Date 10/18/2019
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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