510(k) K251936
- Device
- Ceribell Delirium Monitor System
- Applicant
- Ceribell, Inc.
- 510(k) number
- K251936
- Product code
- NCG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-08
- Date received
- 2025-06-24
- Regulation
- 882.1440
- Classification name
- Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Raymond Woo
- Address
- 360 N. Pastoria Ave. Sunnyvale CA US 94085 94085
FDA Registration Numbers#
- 3013671918