K-number	K160569
Device name	NeuGuide
Applicant	Pop Medical Solutions
Product code	PBQ
Device class	Class II
Decision date	Jul 6, 2016
Decision	Substantially Equivalent
Regulation	884.4530

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Source

View the full FDA submission: accessdata.fda.gov

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NeuGuide

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