FDA.reportPublic FDA data

NEUROFAX

Primary DI
00841983103834
Brand
NEUROFAX
Company
NIHON KOHDEN AMERICA, INC.
Model
JE-120A-24
Catalog number
JE-120A-24
Device description
256 CHANNEL AMPLIFIER for JE-120A
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLTNon-normalizing quantitative electroencephalograph software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080546000NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200ANihon Kohden America, Inc.2008-08-29OLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841983103834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841983103834008419831038348419831038340841983103834

GMDN Terms#

Term, Definition table
TermDefinition
Neurophysiologic monitoring systemAn assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
021063219
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841983101493NAYG-101TYG-101T2016-09-19
10841983101509NAYG-111TYG-111T2016-09-19
10841983101516cap-ONEYG-122TYG-122T2016-09-19
10841983101523NAYG-211TYG-211T2016-09-19
10841983101530NAYG-213TYG-213T2016-09-19
10841983101547NAYG-214TYG-214T2016-09-19
10841983101554cap-ONEYG-232TYG-232T2016-09-19
10841983101561cap-ONEYG-242TYG-242T2016-09-19
10841983102766cap-ONEYG-125TYG-125T2016-09-19
10841983102773cap-ONEYG-135TYG-135T2016-09-19
10841983102780cap-ONEYG-225TYG-225T2016-09-19
10841983102797cap-ONEYG-235TYG-235T2016-09-19
00841983100673NAJG-900PJG-900P2016-09-19
00841983101434NATG-101TTG-101T2016-09-19
00841983102295NAOLG-2800AOLG-2800A2016-09-19
00841983102622NATG-900PTG-900P2016-09-19
00841983102639cap-ONETG-920PTG-920P2016-09-19
00841983102646cap-ONETG-921T3TG-921T32016-09-19
00841983102653cap-ONETG-970PTG-970P2016-09-19
10841983101592NAYG-921PYG-921P2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B592SW100WAVi Scan SoftwareWAVI CO.OLT2026-03-25
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B592WK200WAVi Scan KitWAVI CO.OLT2026-03-25
09120109830269encevisAIT Austrian Institute of Technology GmbHOLT2025-08-05
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
08056446901090NExT Station AdvancedEB NEURO SPAOLT2025-05-19
08690020003062BrainView NeuralScanMedeia, Inc.OLT2025-02-05
08056446900673Neurotravel LIGHTEB NEURO SPAOLT2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAOLT2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAOLT2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAOLT2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAOLT2024-12-04
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.OLT2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-06-21
00817111021264Live View Panel Pro Version 2.0Neurotronics, LLCOLT2024-05-09
10884521808270BISCovidien LPOLT2024-04-28
10884521808300BISCovidien LPOLT2024-04-28