Name: Predicase
Price: 199 USD

K-number	K161728
Device name	Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1
Applicant	Microfile Intellectual Property GmbH
Product code	FLL
Device class	Class II
Decision date	Dec 5, 2016
Decision	Substantially Equivalent
Regulation	880.2910

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Source

View the full FDA submission: accessdata.fda.gov

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Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1

Everything you need for a 510(k) submission. Nothing you don't.