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 |