Name: Predicase
Price: 199 USD

K-number	K092447
Device name	DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
Applicant	Hangzhou Hua'An Medical & Health Instruments Co.,
Product code	FLL
Device class	Class II
Decision date	Jan 7, 2010
Decision	Substantially Equivalent
Regulation	880.2910

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Source

View the full FDA submission: accessdata.fda.gov

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DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES

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