FDA.reportPublic FDA data

Pocket EEG Device, EEG Recording Viewer Software

Primary DI
00851420007045
Brand
Pocket EEG Device, EEG Recording Viewer Software
Company
CERIBELL, INC.
Model
SW-00001
Published
2018-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph
OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2
OMBAutomatic Event Detection Software For Full-Montage ElectroencephalographNeurology2
OMCReduced- Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170363000
K191301000
K223504000
K241589000
K251936000
K252070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170363000Ceribell Pocket EEG DeviceCeribell, Inc.2017-05-08OMC
K191301000Ceribell Pocket EEG DeviceCeribell, Inc.2019-09-11OMB
K223504000Ceribell Status Epilepticus MonitorCeribell, Inc.2023-05-23OMB
K241589000Ceribell Seizure Detection SoftwareCeribell, Inc.2025-04-09OMB
K251936000Ceribell Delirium Monitor SystemCeribell, Inc.2025-12-08NCG
K252070000Ceribell Infant Seizure Detection SoftwareCeribell, Inc.2025-11-21OMB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851420007045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851420007045008514200070458514200070450851420007045

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079897397
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851420007076Ceribell EEG Headcap, Small C2512024-03-08
00851420007083Ceribell EEG Headcap, MediumC2522024-03-08
00851420007021Ceribell EEG Headband, small sizeC1512018-03-28
00851420007038Ceribell EEG Headband, medium sizeC1522018-03-28
00851420007052Pocket EEG DeviceC1002021-08-02
00851420007007Pocket EEG DeviceC1002018-01-18

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