BE Plus LTM Amplifier GWI Amplifier
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- BE PLUS LTM EUDAMED
- Device Name
- EEG Family EUDAMED
- Model / Reference
- B9800082000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056446900888 EUDAMED
- Basic UDI-DI
- 080564469EEG_BE EUDAMED
- 510(k) Number
- K121996 FDA 510(k)
- FDA Product Code
- GWL FDA 510(k)
- EMDN Code
- Z12109099 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1835 FDA 510(k)
- Regulation Number
- 882.1835 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The BE Plus LTM Amplifier GWI Amplifier is a physiological signal amplifier designed for neurology applications. It amplifies weak electrical signals from the brain and peripheral nerves, enabling precise monitoring and analysis of neural activity during diagnostic procedures.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as hospitals and neurology clinics. It operates within the constraints of FDA 510(k) clearance and EU MDR compliance, with a classification as a Class II device. Storage and handling follow standard medical equipment protocols, and its regulatory status includes special clearance under the Neurology Advisory Committee.
Frequently asked questions
What clinical applications is the BE Plus LTM Amplifier GWI Amplifier primarily used for?
The BE Plus LTM Amplifier GWI Amplifier is designed for neurology applications, specifically to amplify weak electrical signals from the brain and peripheral nerves. This enables precise monitoring and analysis of neural activity during diagnostic procedures, such as electroencephalography (EEG) or electromyography (EMG) studies.
Is the BE Plus LTM Amplifier GWI Amplifier intended for single-use or reusable clinical settings?
The device is explicitly supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical settings like hospitals and neurology clinics. Proper cleaning and maintenance protocols must be followed to ensure its safe and effective reuse.
What regulatory pathways does the BE Plus LTM Amplifier GWI Amplifier follow in the U.S.?
The device is cleared under the FDA’s 510(k) pathway, specifically through a Special Clearance route via the Neurology Advisory Committee. It is classified as a Class II medical device and is also compliant with the EU’s Medical Device Regulation (MDR).
How should the BE Plus LTM Amplifier GWI Amplifier be stored and handled?
Since it is a reusable medical instrument, storage and handling must adhere to standard protocols for medical equipment. This includes proper cleaning, disinfection, and maintenance to prevent contamination and ensure reliable performance. The manufacturer’s guidelines should be followed for optimal longevity and safety.
Are there different models or sizes available for the BE Plus LTM Amplifier GWI Amplifier?
The provided data lists multiple registration numbers (e.g., 1721676, 3015491430, etc.) under the product code GWL, which may indicate variations or configurations of the device. However, specific details about distinct models or sizes (e.g., differences in amplification range, connectivity, or form factors) are not explicitly described in the data. Contacting the manufacturer would clarify any available variations.
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 | K121996 | Class II | Active |
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Manufacturer
- Manufacturer
- EB Neuro S.p.A.
Sources (2)
- FDA 510(k) K121996 24 fields · synced Sep 18, 2026
- EUDAMED 2a8a7011-77ba-401d-bc6f-ed8b34da1a61 61 fields · synced Jul 14, 2026