FDA Product Code
FDA Product Code QGL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5898
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243289 | ADDNOX (BPSPM1) | Nu Eyne Co., Ltd. | 2025-01-16 | Traditional | PDF ↗ |
| K232991 | BT-1000 | Bistos Co., Ltd. | 2024-08-28 | Traditional | PDF ↗ |
| K233293 | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | Neurosigma, Inc. | 2024-01-16 | Traditional | PDF ↗ |
| K213629 | SMILE | Nu Eyne Co., Ltd. | 2023-02-12 | Traditional | PDF ↗ |
| DEN180041 | Monarch eTNS System | Neurosigma, Inc. | 2019-04-19 | Direct | — |
Product code QGL · Class II · Neurology. Data: openFDA.