FDA.reportPublic FDA data

Zeto ONE Head Unit - Small

Primary DI
B675ONEHUS1
Brand
Zeto ONE Head Unit - Small
Company
ZETO, INC.
Model
ZP-120-11021
Device description
The Zeto ONE Head Unit - Small is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children with head circumference of approximately 45-50 cm, not including newborns. The Head Unit - Small component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.
Published
2025-07-09
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
B675ONEHUS1PrimaryHIBCC0

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
8339386334support@zetoinc.com

Regulatory Flags#

DUNS number
079582566
Device count
1
DM exempt
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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08056446901335BE PLUS PRO [FULL]EB NEURO SPAGWQ2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWQ2024-12-04
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