NEBA Compact EEG System

Primary DI
00863414000314
Brand
NEBA Compact EEG System
Company
NEBA HEALTH, LLC
Model
7200101
Device description
Neuropsychiatric interpretive electroencephalograph assessment aid. Uses a patient's electroencephalograph (eeg) to provide an interpretation of the patient's neuropsychiatric condition.It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis
Published
2016-10-03
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
NCGNeuropsychiatric Interpretative Electroencephalograph Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NCGNeuropsychiatric Interpretative Electroencephalograph Assessment AidNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN110019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN110019000NEBA SYSTEMLexicor Medical Technology, LLC2013-07-15NCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863414000314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863414000314008634140003148634140003140863414000314

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
605190313
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719326465395DeltaScan MonitorProlira B.V.NCG2023-05-11
87193264653958DeltaScan MonitorProlira B.V.NCG2023-05-11