AE-120A EEG Head Set YZ-003A4

GUDID 04931921903582

AE-120A Accessory Kit with belts and forehead pad

NIHON KOHDEN CORPORATION

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Primary Device ID04931921903582
NIH Device Record Keyb41a50b1-a2ff-4124-8c80-561c00f57b14
Commercial Distribution StatusIn Commercial Distribution
Brand NameAE-120A EEG Head Set
Version Model NumberYZ-003A4
Catalog NumberYZ-003A4
Company DUNS690568050
Company NameNIHON KOHDEN CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com
Phone+1(800325-0283
EmailNeurologyTechSupport@nihonkohden.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104931921903582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMCReduced- Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-21
Device Publish Date2019-06-13

On-Brand Devices [AE-120A EEG Head Set]

14931921903053Disposable Electrode for EEG
14931921903046Disposable Electrode for EEG
04931921129975EEG Head Set
04931921903582AE-120A Accessory Kit with belts and forehead pad
04931921903278Disk electrode for EEG

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