FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ceribell Infant Seizure Detection Software
K Number: K252070
·
Decision Nov 21, 2025
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
40
Applicant Total
13
Review Days
143
Basic Information
- Device Name
- Ceribell Infant Seizure Detection Software
- K Number
- K252070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ceribell, Inc.
- Date Received
- July 1, 2025
- Decision Date
- November 21, 2025
- Product Code
- OMB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | FDA class 2 | Neurology |
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