Name: Predicase
Price: 199 USD

K-number	K161933
Device name	The Braun ThermoScan® 3 High Speed Compact Ear Thermometer
Applicant	Kaz USA, Inc., A Helen of Troy Company
Product code	FLL
Device class	Class II
Decision date	Aug 16, 2016
Decision	Substantially Equivalent
Regulation	880.2910

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Source

View the full FDA submission: accessdata.fda.gov

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The Braun ThermoScan® 3 High Speed Compact Ear Thermometer

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