Ceribell EEG Analysis Software— 510(k) K261712
Substantially EquivalentCeribell, Inc.
FDA 510(k) clearance K261712 for Ceribell EEG Analysis Software, Substantially Equivalent on 2026-09-16. Applicant: Ceribell, Inc.. Device class: 2.
Summary
Ceribell EEG Analysis Software is from Ceribell, Inc., filed under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software). Beyond the name and code, the record says nothing about the software.
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). The decision was Substantially Equivalent.
Ceribell filed from Sunnyvale, California. The decision came 117 calendar days after FDA received it (May 22 to September 16, 2026).
Clearance details
- Applicant
- Ceribell, Inc.
- Product code
- Product code OLT
- 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 OLT
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view allAdverse events under product code OLT
product code OLT- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.