FDA Registration
Active
🇺🇸 United States
CERIBELL, INC.
Reg #: 3013671918
·
FEI: 3013671918
·
Expires 2026
Products
5
Proprietary Names
11
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- CERIBELL, INC.
- Registration Number
- 3013671918
- FEI Number
- 3013671918
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 360 N Pastoria Ave
- City
- Sunnyvale
- State
- CA
- ZIP
- 94085
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210805
Owner / Operator
- Firm Name
- Ceribell, Inc.
- Operator Number
- 10055114
- Address
- 360 N Pastoria Ave
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94085
- Country
- US
- Correspondent
- Raymond Woo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2022-11-22 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2022-11-22 |
| Automatic Event Detection Software For Full-Montage Electroencephalograph | OMB | Class 2 | Neurology | No | 2026-04-16 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2026-04-16 |
| Neuropsychiatric Interpretative Electroencephalograph Assessment Aid | NCG | Class 2 | Neurology | No | 2026-04-16 |
Proprietary Names
Ceribell EEG Headband
Ceribell Infant Seizure Detection Software (Clarity)
Ceribell Instant EEG Headcap
ClarityPro
Ceribell Instant EEG Headset
Ceribell Seizure Detection Software (Clarity)
Ceribell Delirium Monitor System
Ceribell EEG Recorder with Clarity
Ceribell Brain Monitor Headband
Ceribell EEG Recorder
Ceribell EEG Headcap
Establishment Types
Manufacture Medical Device