K-number	K011582
Device name	QCU ANALYTICAL SOFTWARE PACKAGE
Applicant	Medis Medical Imaging Systems BV
Product code	LLZ
Device class	Class II
Decision date	Jul 31, 2001
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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QCU ANALYTICAL SOFTWARE PACKAGE

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