GammaCore Sapphire
Non-invasive Vagus Nerve Stimulator - Headache
Electrocore, Inc.
The following data is part of a premarket notification filed by Electrocore, Inc. with the FDA for Gammacore Sapphire.
Pre-market Notification Details
| Device ID | K191830 |
| 510k Number | K191830 |
| Device Name: | GammaCore Sapphire |
| Classification | Non-invasive Vagus Nerve Stimulator - Headache |
| Applicant | Electrocore, Inc. 150 Allen Road, Suite 201 Basking Ridge, NJ 07920 |
| Contact | Mike Romaniw |
| Correspondent | Mike Romaniw Electrocore, Inc. 150 Allen Road, Suite 201 Basking Ridge, NJ 07920 |
| Product Code | PKR |
| CFR Regulation Number | 882.5892 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-09 |
| Decision Date | 2020-03-26 |
Trademark Results [GammaCore Sapphire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GAMMACORE SAPPHIRE 87519426 5897664 Live/Registered |
Electrocore LLC 2017-07-07 |
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