K-number	K063111
Device name	FINOMETER MODEL-2 WITH ACCESSORIES
Applicant	Finapres Medical Systems B.V.
Product code	DXN
Device class	Class II
Decision date	Feb 1, 2007
Decision	Substantially Equivalent
Regulation	870.1130

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Source

View the full FDA submission: accessdata.fda.gov

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FINOMETER MODEL-2 WITH ACCESSORIES

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