Ceribell Brain Monitor Headband
Device Facts
| Record ID | K260363 |
|---|---|
| Device Name | Ceribell Brain Monitor Headband |
| Applicant | Ceribell, Inc. |
| Product Code | GXY · Neurology |
| Decision Date | Apr 3, 2026 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 882.1320 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
