K-number	K161114
Device name	HIGH V+
Applicant	Teknimed Sas
Product code	NDN
Device class	Class II
Decision date	Apr 12, 2017
Decision	Substantially Equivalent
Regulation	888.3027

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Source

View the full FDA submission: accessdata.fda.gov

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HIGH V+

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