Name: Predicase
Price: 199 USD

K-number	K072439
Device name	GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT
Applicant	Ge Medical Systems Ultrasound and Primary Care Dia
Product code	KGI
Device class	Class II
Decision date	Sep 14, 2007
Decision	Substantially Equivalent
Regulation	892.1170

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Source

View the full FDA submission: accessdata.fda.gov

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GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT

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