BE Plus PRO Neurotravel Light Amplifier, Physiological Signal
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242305 FDA 510(k)
- FDA Product Code
- GWL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1835 FDA 510(k)
- Regulation Number
- 882.1835 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BE Plus PRO Neurotravel Light is a physiological signal amplifier designed for neurology applications. It records and processes electrical signals from the nervous system, enabling precise monitoring of brain and peripheral nerve activity for diagnostic and research purposes.
This device is supplied as a reusable medical instrument, intended for use in clinical and research settings. It is classified as Class II under FDA regulations and has received FDA 510(k) clearance as Substantially Equivalent, alongside MDR authorization. The amplifier supports multiple electrode configurations and is intended for use in environments where MRI safety may be a consideration, though specific MRI compatibility details are not provided.
Frequently asked questions
What types of nervous system signals can the BE Plus PRO, Neurotravel LIGHT amplifier record and process?
The BE Plus PRO, Neurotravel LIGHT is designed to record and process electrical signals from both the brain and peripheral nerves, enabling precise monitoring of neurological activity. Its support for multiple electrode configurations makes it versatile for diagnostic and research applications in neurology.
Is the BE Plus PRO, Neurotravel LIGHT intended for use in MRI environments, and if so, what considerations should be taken?
The device is intended for use in environments where MRI safety may be a consideration, though the exact MRI compatibility details are not specified in the provided data. Clinicians should verify compatibility with their specific MRI system and follow safety protocols to ensure proper use.
How is the BE Plus PRO, Neurotravel LIGHT supplied, and is it reusable?
The BE Plus PRO, Neurotravel LIGHT is supplied as a reusable medical instrument, meaning it is designed for repeated use in clinical and research settings. This makes it cost-effective for long-term monitoring and studies.
What regulatory pathways has the BE Plus PRO, Neurotravel LIGHT undergone, and what does this mean for its use?
The device has received FDA 510(k) clearance as Substantially Equivalent (SESE) under the Special clearance type, alongside MDR authorization. This means it has been evaluated and deemed comparable to a legally marketed predicate device in the U.S., ensuring it meets regulatory standards for safety and effectiveness in neurology applications.
What are the primary use cases for the BE Plus PRO, Neurotravel LIGHT in clinical settings?
The device is primarily intended for neurology applications, supporting the recording and processing of electrical signals from the brain and peripheral nerves. It is suitable for diagnostic purposes, such as monitoring neurological activity, as well as research settings where precise signal analysis is required.
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 (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242305 | Class II | Active |
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Manufacturer
- Manufacturer
- EB Neuro S.p.A.
Sources (2)
- FDA 510(k) K242305 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026