K-number	K103737
Device name	OMNI II PATIENT MONITOR
Applicant	Infinium Medical
Product code	MWI
Device class	Class II
Decision date	Jun 2, 2011
Decision	Substantially Equivalent
Regulation	870.2300

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Source

View the full FDA submission: accessdata.fda.gov

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OMNI II PATIENT MONITOR

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