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,…
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.
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1), Shaanxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Zeto ONE Display Unit | Listed by | Zeto, Inc., United States |
| FDA product code | GWQ |
| Device type | Full-Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Repacker / relabeller |
| 510(k) | K233403 |
| Record published | 2025-11-19 |
| Record revised | 2026-05-28 (version 2) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 12 to 106 KiloPascal; Handling environment humidity 45 to 85 % RH; Handling environment temperature -20 to 45 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 45 to 85 % RH; Storage environment temperature 0 to 45 °C |
| Sizes | Length 22 cm; height 9 cm; width 2.2 cm; weight 380 g |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.