FDA.reportPublic FDA data

Pocket EEG Device

Primary DI
00851420007052
Brand
Pocket EEG Device
Company
CERIBELL, INC.
Model
C100
Published
2021-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851420007007PreviousGS10
00851420007052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851420007007008514200070078514200070070851420007007
00851420007052008514200070528514200070520851420007052

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
Serial number
true

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
00851420007045Pocket EEG Device, EEG Recording Viewer SoftwareSW-000012018-03-28
00851420007021Ceribell EEG Headband, small sizeC1512018-03-28
00851420007038Ceribell EEG Headband, medium sizeC1522018-03-28
00851420007007Pocket EEG DeviceC1002018-01-18

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