The following data is part of a De Novo classification by Electrocore, Llc with the FDA for Gammacore Non-invasive Vagus Nerve Stimulator.
DeNovo ID | DEN150048 |
Device Name: | GammaCore Non-invasive Vagus Nerve Stimulator |
Classification | Non-invasive Vagus Nerve Stimulator - Headache |
Applicant | electroCore, LLC 150 Allen Road, Suite 201 Basking Ridge, NJ 07920 |
Contact | Mike Romaniw |
Product Code | PKR |
CFR Regulation Number | 882.5892 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
Review Advisory Board | Neurology |
Classification Advisory | Neurology |
Type | Direct |
Date Received | 2015-10-16 |
Decision Date | 2017-04-14 |
FDA Review | Decision Summary |
Reclassification Order: | Reclassification Order |