The following data is part of a premarket notification filed by Electrocore, Llc with the FDA for Gammacore-s.
| Device ID | K171306 |
| 510k Number | K171306 |
| Device Name: | GammaCore-S |
| Classification | Non-invasive Vagus Nerve Stimulator - Headache |
| Applicant | electroCore, LLC 150 Allen Road, Suite 201 Basking Ridge, NJ 07920 |
| Contact | Mike Romaniw |
| Correspondent | Mike Romaniw electroCore, LLC 150 Allen Road, Suite 201 Basking Ridge, NJ 07920 |
| Product Code | PKR |
| CFR Regulation Number | 882.5892 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-03 |
| Decision Date | 2017-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815203020010 | K171306 | 000 |