Ceribell Status Epilepticus Monitor— 510(k) K223504
Substantially EquivalentCeribell, Inc.
FDA 510(k) clearance K223504 for Ceribell Status Epilepticus Monitor, Substantially Equivalent on 2023-05-23. Applicant: Ceribell, Inc.. Device class: 2.
Clearance details
- Applicant
- Ceribell, Inc.
- Product code
- 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
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