Ceribell, Inc.
FDA 510(k) & PMA Approved Devices — 13 products
Total Devices13
Categories4
Latest Approval2026-04-03
SEC Filings: 1 filings on record. Latest: 10-Q (2026-05-11). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K260363 | Ceribell Brain Monitor Headband | GXY | 2026-04-03 | View |
| 510(k) | K254033 | Ceribell Instant EEG Headset | GXY | 2026-02-09 | View |
| 510(k) | K251936 | Ceribell Delirium Monitor System | NCG | 2025-12-08 | View |
| 510(k) | K252070 | Ceribell Infant Seizure Detection Software | OMB | 2025-11-21 | View |
| 510(k) | K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | GXY | 2025-10-31 | View |
| 510(k) | K241589 | Ceribell Seizure Detection Software | OMB | 2025-04-09 | View |
| 510(k) | K232052 | Ceribell Instant EEG Headband | GXY | 2023-08-08 | View |
| 510(k) | K223504 | Ceribell Status Epilepticus Monitor | OMB | 2023-05-23 | View |
| 510(k) | K223086 | Ceribell Instant EEG Headcap | GXY | 2023-03-22 | View |
| 510(k) | K210805 | Ceribell Instant EEG Headband | GXY | 2021-08-30 | View |
| 510(k) | K191301 | Ceribell Pocket EEG Device | OMB | 2019-09-11 | View |
| 510(k) | K171459 | Ceribell Instant EEG Headband | GXY | 2017-08-21 | View |
| 510(k) | K170363 | Ceribell Pocket EEG Device | OMC | 2017-05-08 | View |
No matching devices.