| K-number | K260363 |
| Device name | Ceribell Brain Monitor Headband |
| Applicant | Ceribell, Inc. |
| Product code | GXY |
| Device class | Class II |
| Decision date | Apr 3, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.1320 |
The Ceribell Brain Monitor Headband is a single-use, non-sterile, disposable EEG electrode device with 10 silver/silver chloride electrodes pre-filled with conductive electrolyte gel, secured on an elastic fabric headband. It is intended for use in routine clinical settings where rapid placement of multiple EEG electrodes is desired, connecting to an EEG recording or monitoring device.
The subject device has the same intended use, similar design, and same product effectiveness as predicate devices. The primary difference is the addition of polyurethane (PUR) foam in the patient-contacting materials for added comfort, while maintaining identical electrical performance (AC impedance ≤2 kΩ, DC offset ≤100 mV), cable length (0.1–3.0 m), and 10 electrode configuration with 10-20 naming convention placement.
ANSI/AAMI EC12 (electrical performance), ANSI/AAMI ES 60601-1 (conductive connection compliance), IEC 60601-2-2 (shelf-life), ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23 (biocompatibility), and FDA's August 2020 guidance on Cutaneous Electrodes for Recording Purposes.
View the full FDA submission: accessdata.fda.gov