FDA.reportPublic FDA data

NA

Primary DI
04931921108819
Brand
NA
Company
NIHON KOHDEN CORPORATION
Model
JE-225AK
Catalog number
JE-225AK
Device description
Flat Pack Mini 64 Channel 1-64
Published
2016-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWQFull-montage Standard Electroencephalograph
GYCELECTRODE, CORTICAL
OLTNon-normalizing quantitative electroencephalograph software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2
GYCElectrode, CorticalNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04931921108819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04931921108819049319211088194931921108819

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)325-0283info@nkusa.com

Regulatory Flags#

DUNS number
690568050
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14931921902902BLUPRO Attachment TapeYS-111P7P263A2026-06-23
04931921049464NAMDI-1000MDI-10002026-05-20
04931921111697NAIF-949PIF-949P12026-05-20
14931921057541cap-ONEYG-213TYG-213T-A12026-04-20
04931921877401BluPRO®TL-601T0P3112026-02-03
14931921010232cap-ONEYG-220TYG-220T2023-05-22
14931921010270cap-ONEYG-221TYG-221T2023-05-22
14931921010300cap-ONEYG-230TYG-230T2023-05-22
14931921010331cap-ONEYG-231TYG-231T2023-05-22
14931921044350cap-ONE`YG-211TYG-211T-A12024-06-21
04931921025727cap-ONETG-980P1TG-980P12022-05-12
14931921838195NAYG-101TYG-101T2016-09-05
14931921869038cap-ONEYG-122TYG-122T2016-09-05
14931921877996NAYG-111TYG-111T2016-09-05
14931921883713cap-ONEYG-125TYG-125T2016-09-05
14931921883744cap-ONEYG-135TYG-135T2016-09-05
14931921885694NAYG-211TYG-211T2016-09-05
14931921886202cap-ONEYG-232TYG-232T2016-09-05
14931921890025NAYG-213TYG-213T2016-09-05
14931921895709cap-ONEYG-242TYG-242T2016-09-05

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Primary DI, Brand, Company table
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18436612824045Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
18436612824052Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.OLT2026-09-04
00650551006992CORTAC®PMT CORPORATIONGYC2026-07-20
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWQ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWQ2026-07-07
00650551006756CORTAC®PMT CORPORATIONGYC2026-06-25
00650551006633CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006640CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006657CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006664CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006671CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006688CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006695CORTAC®PMT CORPORATIONGYC2026-06-04
09120109830269encevisAIT Austrian Institute of Technology GmbHOLT2025-08-05
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08056446901106NExT-DOCKINGEB NEURO SPAOLT2025-05-22
08056446901113NExT-PADEB NEURO SPAOLT2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAOLT2025-05-22
08056446901137NExT-HSEB NEURO SPAOLT2025-05-22
08056446901168NExT-AMPEB NEURO SPAOLT2025-05-22
08056446901199NExT-ASEB NEURO SPAOLT2025-05-22
08056446901205NExT StationEB NEURO SPAOLT2025-05-22
00848530093693Suction KitSunset Healthcare Solutions, Inc.GYC2025-05-19
08056446901090NExT Station AdvancedEB NEURO SPAOLT2025-05-19
08690020003062BrainView NeuralScanMedeia, Inc.OLT2025-02-05
08690020003062BrainView NeuralScanMedeia, Inc.GWQ2025-02-05
08056446900673Neurotravel LIGHTEB NEURO SPAOLT2024-12-04