FDA.reportPublic FDA data

NA

Primary DI
04931921882801
Brand
NA
Company
NIHON KOHDEN CORPORATION
Model
DR-531B-14
Catalog number
DR-531B-14
Device description
Headphones, MEB-9400
Published
2016-09-05
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
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE
IKNElectromyograph, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04931921882801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04931921882801049319218828014931921882801

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential graphic recording systemAn assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)325-0283info@nkusa.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
B006NVHS102NONENeurovision Medical Products, Inc.GWF2025-12-18
08056446900338NeMus 2 600EB NEURO SPAGWF2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWF2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWF2025-05-26
08056446901106NExT-DOCKINGEB NEURO SPAIKN2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWF2025-05-22
08056446901113NExT-PADEB NEURO SPAGWF2025-05-22
08056446901113NExT-PADEB NEURO SPAIKN2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAIKN2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWF2025-05-22
08056446901137NExT-HSEB NEURO SPAGWF2025-05-22
08056446901137NExT-HSEB NEURO SPAIKN2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWF2025-05-22
08056446901168NExT-AMPEB NEURO SPAIKN2025-05-22
08056446901199NExT-ASEB NEURO SPAIKN2025-05-22
08056446901199NExT-ASEB NEURO SPAGWF2025-05-22
08056446901205NExT StationEB NEURO SPAIKN2025-05-22
08056446901205NExT StationEB NEURO SPAGWF2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWF2025-05-19
08056446901090NExT Station AdvancedEB NEURO SPAIKN2025-05-19
B006NVPTKITC3P6WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTKITC3P7WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTKITC3P8WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTST2Nerveana+®Neurovision Medical Products, Inc.GWF2023-12-04
B006NVPTKITC3P652Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P6T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P752Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P7T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P852Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P8T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20