Ceribell EEG Analysis Software
Ceribell, Inc. · Neurology
Open FDA's page for this record- Third party flag
- N
- City
- Sunnyvale
- Advisory committee description
- Neurology
- Address 1
- 360 N. Pastoria Ave.
- Statement or summary
- Summary
- Product code
- OLT
- Zip code
- 94085
- Applicant
- Ceribell, Inc.
- Decision date
- 2026-09-16
- Decision code
- SESE
- Country code
- US
- Device name
- Ceribell EEG Analysis Software
- Advisory committee
- NE
- Contact
- Raymond Woo
- K number
- K261712
- State
- CA
- Date received
- 2026-05-22
- Review advisory committee
- NE
- Postal code
- 94085
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Non-Normalizing Quantitative Electroencephalograph Software
- Medical specialty description
- Neurology
- Regulation number
- 882.1400
- Device class
- 2
- Registration number
- 3005581270, 3016701404, 3020018, 3030154814, 8022257, 3013501110, 3010536822, 3011184129, 8030229, 3008773490, 3007048291, 9617286, 1063925, 3032109181, 3004203820, 3008483389, 3005877899, 3017374042, 9612330, 3038281851, 3011353843, 3012359877, 3001570235, 3008881376, 3027256461, 9611252, 3005783425, 3009156722, 8044004, 2184161, 9610105, 3009077524, 3019388613, 2023374, 3004415095, 3013679558, 3012182497, 3038896098, 3011766844, 3005713796 +31 more
- FEI number
- 3005581270, 3016701404, 3020018, 3030154814, 1000139867, 3013501110, 3010536822, 3011184129, 3008773490, 3007048291, 3032109181, 3004203820, 3008483389, 3005877899, 3017374042, 3038281851, 3011353843, 3012359877, 3001570235, 3008881376, 3027256461, 3005783425, 3009156722, 2023374, 3009077524, 3019388613, 3004415095, 3013679558, 3012182497, 3038896098, 3002807739, 3011766844, 3005713796, 3002624053, 3002809369, 3002807720, 2936999, 3007603826, 3001687738, 3001090553 +31 more