K-number	K073508
Device name	PARKONE
Applicant	Oculus Optikgerate GmbH
Product code	MXK
Device class	Class II
Decision date	Sep 11, 2008
Decision	Substantially Equivalent
Regulation	886.1850

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Source

View the full FDA submission: accessdata.fda.gov

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PARKONE

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