510(k) clearance
Ceribell EEG Analysis Software
- 510(k) number
- K261712
- Applicant
- Ceribell, Inc.
- Decision date
- Sep 16, 2026
- Date received
- May 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OLT
- Device type
- Non-Normalizing Quantitative Electroencephalograph Software
- Device class
- Class II
- Regulation
- 21 CFR 882.1400
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Sunnyvale, CA, US