K-number	DEN150048
Device name	gammaCore Non-invasive Vagus Nerve Stimulator
Applicant	Electrocore, LLC
Product code	PKR
Device class	Class II
Decision date	Apr 14, 2017
Decision	Not Substantially Equivalent
Regulation	882.5892

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Source

View the full FDA submission: accessdata.fda.gov

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gammaCore Non-invasive Vagus Nerve Stimulator

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