K-number	K130884
Device name	XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION
Applicant	Ge Medical Systems F.I. Haifa
Product code	LLZ
Device class	Class II
Decision date	Apr 12, 2013
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION

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