K-number	K140269
Device name	HERMES MEDICAL IMAGING SUITE V5.4
Applicant	Hermes Medical Solutions AB
Product code	KPS
Device class	Class II
Decision date	May 8, 2014
Decision	Substantially Equivalent
Regulation	892.1200

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Source

View the full FDA submission: accessdata.fda.gov

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HERMES MEDICAL IMAGING SUITE V5.4

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