Ceribell Monitor— 510(k) K261101
Substantially EquivalentCeribell, Inc.
FDA 510(k) clearance K261101 for Ceribell Monitor, Substantially Equivalent on 2026-06-30. Applicant: Ceribell, Inc.. Device class: 2.
Summary
The Ceribell Monitor from Ceribell is filed under OMC, reduced-montage standard electroencephalographs. The record doesn't describe the monitor beyond its name and the code name.
Class II, 21 CFR 882.1400. Neurology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Ceribell filed from Sunnyvale, California. The decision came 89 calendar days after FDA received it (April 2 to June 30, 2026).
Clearance details
- Applicant
- Ceribell, Inc.
- Product code
- Product code OMC
- 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 OMC
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