Ceribell Instant EEG Headband
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232052 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ceribell Instant EEG Headband is a device designed for electroencephalography (EEG) monitoring. It is intended for use in clinical settings to acquire and display EEG signals for the assessment of brain activity.
The device is supplied as a single-use, non-sterile headband and is used in neurology environments. It has received FDA 510(k) clearance under product code GXY and is manufactured by Ceribell, Inc. in Sunnyvale, California.
Frequently asked questions
What is the Ceribell Instant EEG Headband used for?
The Ceribell Instant EEG Headband is designed for electroencephalography (EEG) monitoring to acquire and display EEG signals for the assessment of brain activity in clinical neurology environments.
How is the Ceribell Instant EEG Headband supplied and is it reusable?
The device is supplied as a single-use, non-sterile headband, meaning it is intended for one-time use only and should not be reprocessed or reused after initial application.
What regulatory pathway was used for the Ceribell Instant EEG Headband?
The Ceribell Instant EEG Headband received FDA 510(k) clearance under product code GXY, indicating it was found substantially equivalent to a legally marketed predicate device.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232052 | Class II | Active |
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Manufacturer
- Manufacturer
- Ceribell, Inc.
Sources (1)
- FDA 510(k) K232052 24 fields · synced Sep 23, 2026