K-number	K082486
Device name	GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
Applicant	Bayer Healthcare, LLC
Product code	NBW
Device class	Class II
Decision date	Oct 8, 2008
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE

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