K-number	K180222
Device name	Reaxon Plus
Applicant	Medovent GmbH
Product code	JXI
Device class	Class II
Decision date	Apr 24, 2018
Decision	Substantially Equivalent
Regulation	882.5275

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Source

View the full FDA submission: accessdata.fda.gov

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Reaxon Plus

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