K-number	K140620
Device name	SPORVIEW PLUS BI TEST PACK
Applicant	Crosstex International
Product code	FRC
Device class	Class II
Decision date	Aug 7, 2014
Decision	Substantially Equivalent
Regulation	880.2800

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Source

View the full FDA submission: accessdata.fda.gov

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SPORVIEW PLUS BI TEST PACK

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