FDA.reportPublic FDA data

510(k) K241589

Device
Ceribell Seizure Detection Software
Applicant
Ceribell, Inc.
510(k) number
K241589
Product code
OMB
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-09
Date received
2024-06-03
Regulation
882.1400
Classification name
Automatic Event Detection Software For Full-Montage Electroencephalograph
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#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OMB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K240408REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, Inc.2024-10-17
K240993encevis (2.1)Ait Austrian Institute of Technology GmbH2024-09-27
K231068autoSCOREHolberg Eeg AS2024-01-07
K231779REMI AI Discrete Detection ModuleEpitel, Inc.2024-01-03
K222450LVIS NeuroMatchLVIS Corporation2023-06-09
K223504Ceribell Status Epilepticus MonitorCeribell, Inc.2023-05-23
K222002Persyst 15 EEG Review and Analysis SoftwarePersyst Development Corporation2022-12-30
K211452EncevisAustrian Institute of Technology GmbH2021-12-02
K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2020-05-18
K191301Ceribell Pocket EEG DeviceCeribell, Inc.2019-09-11
K182181Persyst 14 EEG Review and Analysis SoftwarePersyst Development Corporation2018-11-29