Ceribell Neurology Review Software— 510(k) K260998
Substantially EquivalentCeribell, Inc.
FDA 510(k) clearance K260998 for Ceribell Neurology Review Software, Substantially Equivalent on 2026-06-24. Applicant: Ceribell, Inc.. Device class: 2.
Summary
Ceribell Neurology Review Software from Ceribell is filed under OMB, automatic event detection software for full-montage electroencephalographs. The record doesn't describe the software beyond its name and the code name.
Class II, 21 CFR 882.1400. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Ceribell filed from Sunnyvale, California. The decision came 90 calendar days after FDA received it (March 26 to June 24, 2026).
Clearance details
- Applicant
- Ceribell, Inc.
- Product code
- Product code OMB
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code OMB
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