K-number	K191283
Device name	Infrared Thermometer, Breeze model
Applicant	Suzhou Melodicare Medical Technology Co., Ltd.
Product code	FLL
Device class	Class II
Decision date	Oct 18, 2019
Decision	Substantially Equivalent
Regulation	880.2910

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View the full FDA submission: accessdata.fda.gov

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Infrared Thermometer, Breeze model

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