FDA.reportPublic FDA data

CERIBELL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30136719183013671918CERIBELL, INC.1N2026-01-01360 N Pastoria Ave Sunnyvale CA US 94085

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2086471908580074K260363Ceribell Brain Monitor HeadbandGXY2026-04-03
2086471779516817K254033Ceribell Instant EEG HeadsetGXY2026-02-09
2086472042630766K252070Ceribell Infant Seizure Detection SoftwareOMB2025-11-21
2086471236286265K251936Ceribell Delirium Monitor SystemNCG2025-12-08
2086471011786574K251381Ceribell Instant EEG Headcap (Small: C251, Medium: C252)GXY2025-10-31
2086471457759838K241589Ceribell Seizure Detection SoftwareOMB2025-04-09
2086472058087895K232052Ceribell Instant EEG HeadbandGXY2023-08-08
2086471518019139K223504Ceribell Status Epilepticus MonitorOMB2023-05-23
2086471348825684K223086Ceribell Instant EEG HeadcapGXY2023-03-22
2086471457760375K210805Ceribell Instant EEG HeadbandGXY2021-08-30
2086471799153418K191301Ceribell Pocket EEG DeviceOMB2019-09-11
2086471724699017K171459Ceribell Instant EEG HeadbandGXY2017-08-21
2086471143071401K170363Ceribell Pocket EEG DeviceOMC2017-05-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GXY72026-04-03
OMB42025-11-21
NCG12025-12-08
OMC12017-05-08

PMN#

GUDID#