FDA.reportPublic FDA data

Zeto ONE Long-Term Electrode Set

Primary DI
B675ONELTES1
Brand
Zeto ONE Long-Term Electrode Set
Company
ZETO, INC.
Model
ZP-200-67031
Device description
"The Zeto ONE Long-Term Electrode Set is a part of the Zeto ONE, which is an EEG system intended for prescription use in a healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Long-Term electrode set contains 17 ""Soft Flex"" electrodes, 3 ""Soft Flat"" electrodes and 4 ECG Electrodes necessary to conduct a single EEG recording session."
Published
2025-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B675ONELTES1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp electrode, single-useA noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool and dry place, away from direct sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8339386334support@zetoinc.com

Regulatory Flags#

DUNS number
079582566
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
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
B675ONEREF1Zeto ONE REF Cable ExtensionZP-230-300612024-06-11

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Primary DI, Brand, Company table
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