K-number	K083181
Device name	QV-9000 UNIVERSAL SYSTEM
Applicant	Quantum Medical Imaging, LLC
Product code	KPR
Device class	Class II
Decision date	Nov 26, 2008
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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QV-9000 UNIVERSAL SYSTEM

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