K-number	K213084
Device name	Ear Thermometer, Model ET005, ET008, ET009
Applicant	Guangzhou Berrcom Medical Device Co., Ltd.
Product code	FLL
Device class	Class II
Decision date	Feb 25, 2022
Decision	Substantially Equivalent
Regulation	880.2910

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View the full FDA submission: accessdata.fda.gov

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Ear Thermometer, Model ET005, ET008, ET009

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