Identity
- Trade Name
- Zeto ONE Head Unit - Regular FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- The Zeto ONE Head Unit - Regular 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 with head circumference of approximately 50-65 cm, not including newborns. The Head Unit - Regular component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity. FDA UDI
- Model / Reference
- ZP-120-11031 FDA UDI
- Description
- The Zeto ONE Head Unit - Regular 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 with head circumference of approximately 50-65 cm, not including newborns. The Head Unit - Regular component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B675ONEHUL1 FDA UDI
- 510(k) Number
- K233403 FDA UDI
- FDA Product Code
- GWQ FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 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
Yes
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electroencephalograph
Zeto ONE Head Unit - Regular 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 Electrode Set — Basic — ZETO INC
- Zeto ONE HEOG Cable Extension Set — ZETO INC
- Zeto ONE Head Unit — 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 a4169b82-3ea7-43aa-8062-11e1948e93f1 35 fields · synced May 30, 2026