K-number	K163687
Device name	OLINDA EXM
Applicant	Hermes Medical Solutions AB
Product code	IYX
Device class	Class I
Decision date	Jul 19, 2017
Decision	Substantially Equivalent
Regulation	892.1100

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Source

View the full FDA submission: accessdata.fda.gov

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OLINDA EXM

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