Name: Predicase
Price: 199 USD

K-number	K113286
Device name	ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS
Applicant	Ge Medical Systems Lunar
Product code	KGI
Device class	Class II
Decision date	Apr 27, 2012
Decision	Substantially Equivalent
Regulation	892.1170

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Source

View the full FDA submission: accessdata.fda.gov

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ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS

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