Identifiers
- 510(k) Number
- K233403 FDA 510(k)
- FDA Product Code
- GWQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1400 FDA 510(k)
- Regulation Number
- 882.1400 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Frequently asked questions
What is the Flexset System used for?
The Flexset System is a portable electroencephalograph device designed for full-montage EEG monitoring in hospitals and clinics. It is used for triage, routine, and continuous EEG testing to assess brain activity.
Is the Flexset System reusable or single-use?
The Flexset System is intended for single-use applications. It is supplied as a Class II medical device and should be used according to manufacturer instructions to ensure proper functionality and patient safety.
What is the regulatory status of the Flexset System?
The Flexset System is a Class II medical device with FDA 510(k) clearance K233403 under product code GWQ. It is regulated under 21 CFR 882.1400, which covers electroencephalograph devices.
Is the Flexset System MRI safe?
The Flexset System is not specified as MRI safe. Healthcare providers should ensure the device is used in appropriate environments and follow manufacturer guidelines regarding safety precautions in different clinical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Zeto, Inc. ℅ Mary Vater Consulting Partner Medical Device Academy, Inc ..., EEG Portable Headset: FDA-approved EEG device | Zeto Inc., K233403 - Flexset System | FDA 510 (k) | Zeto, Inc., Our Story | Dry EEG Headset | EEG Monitoring Company - Zeto Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233403 | Class II | Active |
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Manufacturer
- Manufacturer
- Zeto Inc
- FDA Applicant
- Zeto, Inc.
Sources (1)
- FDA 510(k) K233403 24 fields · synced Sep 24, 2026