FDA UDI
In Commercial Distribution
🇺🇸 United States
Zeto ONE Display Unit
DI: B675PDDU0
·
Model: ZP-140-11011
·
ZETO INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Zeto ONE Display Unit
- Primary DI
- B675PDDU0
- Version / Model
- ZP-140-11011
- Company Name
- ZETO INC
- Labeler DUNS
- 079582566
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-19
- Public Version
- 1
- Public Version Date
- 2025-11-27
- Public Version Status
- New
- Public Device Record Key
- 6dc7d777-ee11-4630-95cb-cf4a530036d1
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B675PDDU0 | HIBCC |
Customer Contacts
- Phone
- 8339386334
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233403 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 22 | Centimeter | |
| Height | 9 | Centimeter | |
| Width | 2.2 | Centimeter | |
| Weight | 380 | Gram |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 12 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 45 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 45 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 45 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 45 Degrees Celsius