510(k) K203546
- Device
- GammaCore Sapphire
- Applicant
- Electrocore, Inc.
- 510(k) number
- K203546
- Product code
- PKR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-12
- Date received
- 2020-12-04
- Regulation
- 882.5892
- Classification name
- Non-invasive Vagus Nerve Stimulator - Headache
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Mike Romaniw
- Address
- 150 Allen Rd., Suite 201 Basking Ridge NJ US 07920 07920
FDA Registration Numbers#
- 3015529603
Source Documents#
Other 510(k) Records For Product Code PKR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211856 | gammaCore Sapphire | Electrocore, Inc. | 2021-09-10 |
| 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 |
| DEN150048 | gammaCore Non-invasive Vagus Nerve Stimulator | Electrocore, LLC | 2017-04-14 |
Legacy Summary#
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FDA Review#
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