FDA UDI
In Commercial Distribution
🇺🇸 United States
Zeto ONE AUX Cable Extension Set
DI: B675ONEAUX1
·
Model: ZP-230-30021
·
ZETO INC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Zeto ONE AUX Cable Extension Set
- Primary DI
- B675ONEAUX1
- Version / Model
- ZP-230-30021
- Company Name
- ZETO INC
- Labeler DUNS
- 079582566
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-11
- Public Version
- 1
- Public Version Date
- 2024-06-19
- Public Version Status
- New
- Public Device Record Key
- 41712a02-43e5-4803-ab74-17bff4ee09f6
Device Description
The Zeto ONE AUX Cable Extension Set is an accessory 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 AUX Cable Extension Set is a pair of lead wires with 2.5 mm jack connectors at one end, and snap-on connectors for commonly available adhesive electrodes at the other end. The lead wires are used to record auxiliary signals.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 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 | B675ONEAUX1 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233403 | 000 |