510(k) DEN150048
- Device
- gammaCore Non-invasive Vagus Nerve Stimulator
- Applicant
- Electrocore, LLC
- 510(k) number
- DEN150048
- Product code
- PKR
- Decision
- Unknown (DENG)
- Decision date
- 2017-04-14
- Date received
- 2015-10-16
- Regulation
- 882.5892
- Classification name
- Non-Invasive Vagus Nerve Stimulator - Headache
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Mike Romaniw
- Address
- 150 Allen Rd., Suite 201 Basking Ridge NJ US 07920 07920
FDA Registration Numbers#
- 3015529603
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PKR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211856 | gammaCore Sapphire | Electrocore, Inc. | 2021-09-10 |
| K203546 | gammaCore Sapphire | Electrocore, Inc. | 2021-02-12 |
| K191830 | gammaCore Sapphire | Electrocore, Inc. | 2020-03-26 |
| K182369 | gammaCore Sapphire | Electrocore, Inc. | 2018-11-27 |
| K180538 | gammaCore Sapphire | Electrocore, LLC | 2018-03-30 |
| K173442 | gammaCore-S | Electrocore, LLC | 2018-01-23 |
| K172270 | gammaCore-2 | Eletrocore, LLC | 2017-12-07 |
| K171306 | gammaCore-S | Electrocore, LLC | 2017-05-30 |