AccessGUDID - DEVICE: Zeto ONE Display Unit (B675PDDU0)

GUDID

Device Identifier (DI) Information

Brand Name: Zeto ONE Display Unit
Version or Model: ZP-140-11011
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZETO, INC.

Primary DI Number: B675PDDU0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079582566 *Terms of Use

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 signals transmit the obtained data to the Zeto Cloud Platform display the currently detected EEG signals control the recording process The Display Unit is supplied with a USB power delivery-capable charger and an appropriate type C charging cable.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11467	Electroencephalograph	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWQ	Full-Montage Standard Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233403	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 12 and 106 KiloPascal
Handling Environment Humidity: between 45 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 45 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 45 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 22 Centimeter
Height: 9 Centimeter
Width: 2.2 Centimeter
Weight: 380 Gram

Device Record Status

Public Device Record Key: 6dc7d777-ee11-4630-95cb-cf4a530036d1
Public Version Date: May 28, 2026
Public Version Number: 2
DI Record Publish Date: November 19, 2025