FDA.reportPublic FDA data

Zeto ONE Display Unit

Primary DI
B675PDDU0
Brand
Zeto ONE Display Unit
Company
ZETO, INC.
Model
ZP-140-11011
Device description
The Zeto ONE Display Unit (DU) is a part of the Zeto ONE system, which is an EEG system intended to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. Perscription use only.The Display Unit is the parent device of the Flexset System, intended to:power the Zeto ONE Head Unit.aquire the Zeto ONE Head Unit's signalstransmit the obtained data to the Zeto Cloud Platformdisplay the currently detected EEG signalscontrol the recording processThe Display Unit is supplied with a USB power delivery-capable charger and an appropriate type C charging cable.
Published
2025-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K233403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233403000Flexset SystemZeto, Inc.2024-04-30GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B675PDDU0PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height9Centimeter
Length22Centimeter
Weight380Gram
Width2.2Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure12 KiloPascal106 KiloPascal
Handling Environment Humidity45 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius45 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity45 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8339386334support@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
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
B675ONEREF1Zeto ONE REF Cable ExtensionZP-230-300612024-06-11

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