FDA.reportPublic FDA data

AE-120A EEG Head Set

Primary DI
04931921903582
Brand
AE-120A EEG Head Set
Company
NIHON KOHDEN CORPORATION
Model
YZ-003A4
Catalog number
YZ-003A4
Device description
AE-120A Accessory Kit with belts and forehead pad
Published
2019-06-13
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
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMCReduced- Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183529000AE-120A EEG Head SetNihon Kohden Corporation2019-03-19OMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04931921903582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04931921903582049319219035824931921903582

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(800325-0283NeurologyTechSupport@nihonkohden.com

Regulatory Flags#

DUNS number
690568050
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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14931921057541cap-ONEYG-213TYG-213T-A12026-04-20
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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

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