K-number	K160774
Device name	IonoStar Plus
Applicant	Voco GmbH
Product code	EMA
Device class	Class II
Decision date	Aug 3, 2016
Decision	Substantially Equivalent
Regulation	872.3275

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Source

View the full FDA submission: accessdata.fda.gov

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IonoStar Plus

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