Name: Predicase
Price: 199 USD

K-number	K102935
Device name	INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A
Applicant	Kingtech Enterprise, Ltd.
Product code	FLL
Device class	Class II
Decision date	May 27, 2011
Decision	Substantially Equivalent
Regulation	880.2910

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Source

View the full FDA submission: accessdata.fda.gov

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INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A

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