Flexset System
by Zeto Inc
510(k) K233403
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK233403 | Date30 Apr 2024 | StatusActive |
Official records
- FDA 510(k) database K233403
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GWQ
- FDA applicant
- Zeto, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Flexset System is a portable electroencephalograph device that provides full-montage EEG monitoring. It is designed for use in hospitals and clinics for triage, routine, and continuous EEG testing.
The Flexset System is supplied as a Class II medical device under product code GWQ, with FDA 510(k) clearance K233403. It is intended for single-use applications and is regulated under 21 CFR 882.1400. The device is not specified as MRI safe and requires appropriate storage conditions as per manufacturer instructions.
Devices cleared under K233403
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Zeto All-in-One Medical Grade PC ZP-340-70001 | ZP-340-70001 | B675MM0 | On the market | |
| Zeto Extension Unit ZP-141-11001 | ZP-141-11001 | B675FSEU0 | On the market | |
| Zeto ONE AUX Cable Extension Set ZP-230-30021 | ZP-230-30021 | B675ONEAUX1 | On the market | |
| Zeto ONE Disinfection Container with Lid ZP-301-10001 | ZP-301-10001 | B675DC0 | On the market | |
| Zeto ONE Display Unit ZP-140-11001 | ZP-140-11001 | B675ONEDU0 | On the market | |
| Zeto ONE Display Unit ZP-140-11011 | ZP-140-11011 | B675PDDU0 | Length 22 cm; Height 9 cm; Width 2.2 cm; Weight 380 g | On the market |
| Zeto ONE ECG Cable Extension Set ZP-230-30011 | ZP-230-30011 | B675ONEECG1 | On the market | |
| Zeto ONE Electrode Set — Basic ZP-200-67001 | ZP-200-67001 | B675ONEESB1 | On the market | |
| Zeto ONE EMG Cable Extension Set ZP-230-30051 | ZP-230-30051 | B675ONEEMG1 | On the market | |
| Zeto ONE Head Unit - Regular ZP-120-11031 | ZP-120-11031 | B675ONEHUL1 | On the market | |
| Zeto ONE Head Unit - Regular ZP-120-11031 | ZP-120-11031 | B675ONEHUL0 | On the market | |
| Zeto ONE Head Unit - Small ZP-120-11021 | ZP-120-11021 | B675ONEHUS1 | On the market | |
| Zeto ONE Head Unit - Small ZP-120-11021 | ZP-120-11021 | B675ONEHUS0 | On the market | |
| Zeto ONE Head Unit ZP-120-11011 | ZP-120-11011 | B675ONEHU1 | On the market | |
| Zeto ONE HEOG Cable Extension Set ZP-230-30031 | ZP-230-30031 | B675ONEHEOG1 | On the market | |
| Zeto ONE REF Cable Extension ZP-230-30061 | ZP-230-30061 | B675ONEREF1 | On the market | |
| Zeto ONE VEOG Cable Extension Set ZP-230-30041 | ZP-230-30041 | B675ONEVEOG1 | On the market | |
| Zeto TTL Extension Unit ZP-141-11011 | ZP-141-11011 | B675FSTEU0 | On the market |
Similar devices
Other devices filed under FDA product code GWQ (Full-Montage Standard Electroencephalograph).
- EEG Leads, 0.6m, reusable, 9 pcs 5947804 by Draeger Medical Systems, Inc.
- NICOLET VOYAGEUR by Nicolet Instrument Corp.
- HORIZON 2000 EEG MONITORING OPTION by Mennen Medical, Inc.
- Neuronaute with IceCap 2 & IceCap 2 Small by Bioserenity Sas
- BUSHEL OFF-HEAD PREAMPLIFIER by Oxford Medilog, Inc.
- ELECTROENCEPHALOGRAPH EEG by Nicolet Biomedical Instruments
- EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH by Teca, Inc.
- VIDEO EEG OPTION MODIFICATION by Esaote Biomedica Spa
- MENTOR EEG SYSTEM by Oxford Medilog, Inc.
- NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM by Cyberkinetics, Inc.