Identity
- Trade Name
- Zeto ONE Electrode Set — Basic FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDI
- Device Name
- The Zeto ONE Electrode Set — Basic is a part of the Zeto ONE, which is an EEG system intended for prescription use in a 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 electrode set contains 17 "Soft Flex" electrodes, 3 "Soft Flat" electrodes necessary to conduct a single EEG recording session. FDA UDI
- Model / Reference
- ZP-200-67001 FDA UDI
- Description
- The Zeto ONE Electrode Set — Basic is a part of the Zeto ONE, which is an EEG system intended for prescription use in a 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 electrode set contains 17 "Soft Flex" electrodes, 3 "Soft Flat" electrodes necessary to conduct a single EEG recording session. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B675ONEESB1 FDA UDI
- 510(k) Number
- K233403 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analytical scalp electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Analytical scalp electrode, single-use
Zeto ONE Electrode Set — Basic by Zeto Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K233403 also covers:
- Zeto All-in-One Medical Grade PC — ZETO INC
- Zeto ONE AUX Cable Extension Set — ZETO INC
- Zeto ONE Disinfection Container with Lid — ZETO INC
- Zeto ONE Display Unit — ZETO INC
- Zeto ONE ECG Cable Extension Set — ZETO INC
- Zeto ONE EMG Cable Extension Set — ZETO INC
- Zeto ONE HEOG Cable Extension Set — ZETO INC
- Zeto ONE Head Unit — ZETO INC
- Zeto ONE Head Unit - Regular — ZETO INC
- Zeto ONE Head Unit - Small — ZETO INC
- Zeto ONE REF Cable Extension — ZETO INC
- Zeto ONE VEOG Cable Extension Set — ZETO INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Zeto Inc
Sources (1)
- FDA UDI 62ac8604-3128-4d52-b8c0-b7f9c1ab9c66 36 fields · synced May 31, 2026