FDA Product Code
FDA Product Code PKR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5892
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K211856 | gammaCore Sapphire | Electrocore, Inc. | 2021-09-10 | Traditional | PDF ↗ |
| K203546 | gammaCore Sapphire | Electrocore, Inc. | 2021-02-12 | Traditional | PDF ↗ |
| K191830 | gammaCore Sapphire | Electrocore, Inc. | 2020-03-26 | Traditional | PDF ↗ |
| K182369 | gammaCore Sapphire | Electrocore, Inc. | 2018-11-27 | Traditional | PDF ↗ |
| K180538 | gammaCore Sapphire | Electrocore, LLC | 2018-03-30 | Special | PDF ↗ |
| K173442 | gammaCore-S | Electrocore, LLC | 2018-01-23 | Traditional | PDF ↗ |
| K172270 | gammaCore-2 | Eletrocore, LLC | 2017-12-07 | Traditional | PDF ↗ |
| K171306 | gammaCore-S | Electrocore, LLC | 2017-05-30 | Special | PDF ↗ |
| DEN150048 | gammaCore Non-invasive Vagus Nerve Stimulator | Electrocore, LLC | 2017-04-14 | Direct | — |
Product code PKR · Class II · Neurology. Data: openFDA.