FDA.reportPublic FDA data

Nihon Kohden, EEG-1200A Series Neurofax

Primary DI
04931921007693
Brand
Nihon Kohden, EEG-1200A Series Neurofax
Company
NIHON KOHDEN CORPORATION
Model
KC-001A-01
Catalog number
KC-001A-01
Device description
Cart (Stand), used with Electrode junction box or Flash lamp assembly
Published
2019-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWCANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE
GWQFull-montage Standard Electroencephalograph
OLTNon-normalizing quantitative electroencephalograph software
OLVStandard polysomnograph with electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWCAntisera, All Types, Streptococcus PneumoniaeMicrobiology1
GWFStimulator, Electrical, Evoked ResponseNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04931921007693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04931921007693049319210076934931921007693

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trolleyA cart used to transport medical and surgical instruments, and sometimes sterile supplies, from a central supply station or sterilization department to appropriate areas of the hospital [e.g., the operating room (OR)]. In sterilizing departments the trolley may be used in the sterilizing process, and for sterilized instruments the cart may be designed to accommodate sterile wraps/packaging and/or cases. This trolley (cart) can be closed or open (open trolleys are usually covered with fabric during transport).

Contacts#

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

Regulatory Flags#

DUNS number
690568050
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
14931921899295NAYG-214TYG-214T2016-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
08720256698302Onera STS 2Onera B.V.OLV2026-05-15
08720256698319Onera STS 2Onera B.V.OLV2026-05-15
08720256698326Onera STS 2Onera B.V.OLV2026-05-15
08720256698333Onera STS 2Onera B.V.OLV2026-05-15
08720256698340Onera STS 2Onera B.V.OLV2026-05-15
08720256698357Onera STS 2Onera B.V.OLV2026-05-15
08720256698364Onera STS 2Onera B.V.OLV2026-05-15
08720256698371Onera STS 2Onera B.V.OLV2026-05-15
08720256698463Onera STSOnera B.V.OLV2026-05-15
08720256698487Onera STSOnera B.V.OLV2026-05-15
08720256698494Onera STSOnera B.V.OLV2026-05-15
08720256698500Onera STSOnera B.V.OLV2026-05-15
08720256698517Onera STSOnera B.V.OLV2026-05-15
08720256698524Onera STSOnera B.V.OLV2026-05-15
08720256698531Onera STSOnera B.V.OLV2026-05-15
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDOLV2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDOLV2026-03-12
09120109830269encevisAIT Austrian Institute of Technology GmbHOLT2025-08-05
08056446900338NeMus 2 600EB NEURO SPAGWF2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWF2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWF2025-05-26
08056446901106NExT-DOCKINGEB NEURO SPAGWF2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAOLT2025-05-22
08056446901113NExT-PADEB NEURO SPAOLT2025-05-22
08056446901113NExT-PADEB NEURO SPAGWF2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAOLT2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWF2025-05-22
08056446901137NExT-HSEB NEURO SPAGWF2025-05-22
08056446901137NExT-HSEB NEURO SPAOLT2025-05-22