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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 K191283
Device Name Infrared Thermometer, Breeze model
Applicant
Suzhou Melodicare Medical Technology Co., Ltd.
Bldg. Rm. 301, No 32 Hongxi Rd., Suzhou High-Tech Zone
Suzhou,  CN 215163
Applicant Contact Xiaoqian Zou
Correspondent
Suzhou Melodicare Medical Technology Co., Ltd.
Bldg. Rm. 301, No 32 Hongxi Rd., 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
Predetermined Change
Control Plan Authorized		 No
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