FDA.reportPublic FDA data

WR19

Primary DI
B675WR190
Brand
WR19
Company
ZETO, INC.
Model
ZP-100-11001
Device description
EEG Headset
Published
2019-08-15
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
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172735000WR19 SystemZeto, Inc.2018-04-17GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B675WR191PackageHIBCC1In Commercial Distribution
B675WR190PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
833 938 6334info@zetoinc.com

Regulatory Flags#

DUNS number
079582566
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B675DRYFLATS1Dry Flat-SZP-210-41211ZP-210-412112021-01-25
B675DRYFLEXM1Dry Flex-MZP-200-42211ZP-200-422112021-01-25
B675DRYFLEXT1Dry Flex-TZP-200-43211ZP-200-432112021-01-25
B675PDDU0Zeto ONE Display UnitZP-140-110112025-11-19
B675SOFTFLATT1Soft Flat-TZP-210-52011ZP-210-520112021-01-25
B675ONEHUL0Zeto ONE Head Unit - RegularZP-120-110312026-03-13
B675ONEHUS0Zeto ONE Head Unit - SmallZP-120-110212026-03-13
B675ONEHUL1Zeto ONE Head Unit - RegularZP-120-110312025-07-09
B675ONEHUS1Zeto ONE Head Unit - SmallZP-120-110212025-07-09
B675ONELTES1Zeto ONE Long-Term Electrode SetZP-200-670312025-07-09
B675ONESTES1Zeto ONE Short-Term Electrode SetZP-200-670812025-07-09
B675DC0Zeto ONE Disinfection Container with LidZP-301-100012024-11-20
B675MM0Zeto All-in-One Medical Grade PCZP-340-700012024-11-20
B675ONEAUX1Zeto ONE AUX Cable Extension SetZP-230-300212024-06-11
B675ONEDU0Zeto ONE Display UnitZP-140-110012024-06-11
B675ONEECG1Zeto ONE ECG Cable Extension SetZP-230-300112024-06-11
B675ONEEMG1Zeto ONE EMG Cable Extension SetZP-230-300512024-06-11
B675ONEESB1Zeto ONE Electrode Set — BasicZP-200-670012024-06-11
B675ONEHEOG1Zeto ONE HEOG Cable Extension SetZP-230-300312024-06-11
B675ONEHU1Zeto ONE Head UnitZP-120-110112024-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWQ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWQ2026-07-07
B592SW100WAVi Scan SoftwareWAVI CO.GWQ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWQ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWQ2026-03-25
B675PDDU0Zeto ONE Display UnitZETO, INC.GWQ2025-11-19
08690020003062BrainView NeuralScanMedeia, Inc.GWQ2025-02-05
08056446900673Neurotravel LIGHTEB NEURO SPAGWQ2024-12-04
08056446900680Neurotravel LIGHT Base UnitEB NEURO SPAGWQ2024-12-04
08056446900895BE PLUS PRO LIGHTEB NEURO SPAGWQ2024-12-04
08056446900901BE PLUS PRO STANDARDEB NEURO SPAGWQ2024-12-04
08056446900918BE PLUS PRO FULLEB NEURO SPAGWQ2024-12-04
08056446900925BE PLUS PRO ADVANCEDEB NEURO SPAGWQ2024-12-04
08056446900932BE PLUS PRO Battery PackEB NEURO SPAGWQ2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAGWQ2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAGWQ2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAGWQ2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWQ2024-12-04
B675ONEECG1Zeto ONE ECG Cable Extension SetZETO, INC.GWQ2024-06-11
18437017440601Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440632Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440663Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440687Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyGWQ2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyGWQ2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyGWQ2023-04-19
00195278524089NAGE Healthcare Finland OyGWQ2023-04-19
09342451002112SiestaCompumedics Usa, Inc.GWQ2020-12-16
09342451001788SiestaCompumedics Usa, Inc.GWQ2020-12-15
08056446900642Galileo NT Line SoftwareEB NEURO SPAGWQ2020-05-25