Identifiers
- 510(k) Number
- K151600 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 R-40 EEG Amplifier is a multi-channel electroencephalograph (EEG) device designed for recording and amplifying electrical activity from the brain. It falls under the category of physiological signal amplifiers, specifically for neurology applications, and is used to monitor brain wave patterns in clinical and research settings.
This device is supplied as part of an EEG system, including a control PC, video monitor, mains isolation transformer, and optional accessories like a USB Photic Stimulator. It is intended for routine EEG and lab monitoring, with components mounted on a wheeled cart for mobility. The device is classified as a Class II medical device under FDA regulations and complies with the Medical Devices Directive (MDD) in Europe. No specific sterility or single-use details are provided, but it is regulated for clinical use in neurology.
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: LIFELINES R40 USER MANUAL Pdf Download | ManualsLib, lifelines neuro R40 EEG Amplifier Series User Manual, PDF lifelines neuro R-40 EEG Amplifier User Guide - Manuals+, lifelines neuro R40 EEG Amplifier Series User Manual
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K151600 | Class II | Active |
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Manufacturer
- Manufacturer
- Lifelines Ltd.
- FDA Applicant
- Lifelines , Ltd.
Sources (2)
- FDA 510(k) K151600 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026