Ceribell EEG Analysis Software
510(k) K261712
Ceribell EEG Analysis Software is a Class II device made by Ceribell, Inc., cleared under FDA 510(k) K261712 on 16 Sep 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK261712 | Date16 Sep 2026 | StatusActive |
Official records
- FDA 510(k) database K261712
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLT
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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