K-number	K143485
Device name	iGuide 2.1
Applicant	Medical Intelligence Medizintechnik GmbH
Product code	IYE
Device class	Class II
Decision date	Mar 4, 2015
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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iGuide 2.1

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