Identity
- Trade Name
- Zeto ONE EMG Cable Extension Set FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- The Zeto ONE EMG 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 EMG 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 electromyoogram signals. FDA UDI
- Model / Reference
- ZP-230-30051 FDA UDI
- Description
- The Zeto ONE EMG 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 EMG 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 electromyoogram signals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B675ONEEMG1 FDA UDI
- 510(k) Number
- K233403 FDA UDI
- FDA Product Code
- GWQ FDA UDIGXY FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electroencephalograph
Zeto ONE EMG Cable Extension Set 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 Electrode Set — Basic — 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 587975a5-4051-4004-9e52-e43a75a6c6e8 35 fields · synced Jun 1, 2026