The Zeto ONE Head Unit 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…
The Zeto ONE Head Unit 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, not including newborns. The Head Unit component of the Zeto ONE is intended to hold electrodes on the subject’s scalp and aquire electric signals produced by human brain activity.
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 Head 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 | 2024-06-11 |
| Record revised | 2026-05-28 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 12 to 106 KiloPascal; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 45 to 85 % RH; Storage environment humidity 45 to 85 % RH; Handling environment temperature 5 to 40 °C; Storage environment atmospheric pressure -20 to 45 °C |
| UDI direct marking | Exempt |
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.