EEG-1260A Neurofax System; JE-940A EEG Amplifier Unit; LS-940A Photic Stimulator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- EEG Amplifier Unit JE-940A EUDAMED
- Device Name
- Electroencephalograph EUDAMED
- Model / Reference
- JE-940AK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04931921023143 EUDAMED
- Basic UDI-DI
- 4931921MD2a0014LQ EUDAMED
- 510(k) Number
- K251366 FDA 510(k)
- FDA Product Code
- OLT FDA 510(k)
- EMDN Code
- Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1400 FDA 510(k)
- Regulation Number
- 882.1400 FDA 510(k)
- Market of Registration
- Germany 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
Yes
Incorporates Medicinal Product
No
The EEG-1260A Neurofax System is a Non-Normalizing Quantitative Electroencephalograph Software designed to record and display electroencephalogram (EEG) waveforms and related vital signals. It integrates with the JE-940A EEG Amplifier Unit to acquire biological signals such as EEG, ECG, EMG, respiration, and photic stimulation responses for diagnostic assessment. The LS-940A Photic Stimulator is included as a component for standardized visual stimulation during EEG monitoring.
This system is intended for clinical use in neurology settings, featuring reusable hardware components with FDA 510(k) clearance and EU MDR compliance. The EEG-1260A and JE-940A units are non-sterile, reusable medical devices, while the LS-940A Photic Stimulator is supplied as part of the system. No MRI safety classifications or single-use specifications are indicated in the regulatory data. Storage and handling follow standard medical device protocols as defined by the manufacturer.
Frequently asked questions
What types of biological signals can the EEG-1260A Neurofax System record and analyze, and how does it integrate with other components for diagnostic use?
The EEG-1260A Neurofax System is designed to record and display electroencephalogram (EEG) waveforms alongside other vital signals such as ECG, EMG, respiration, and photic stimulation responses. It integrates with the JE-940A EEG Amplifier Unit to acquire these signals for diagnostic assessment. The LS-940A Photic Stimulator is included as part of the system to provide standardized visual stimulation during EEG monitoring, ensuring comprehensive evaluation of neurological function.
Are the hardware components of this system reusable or single-use, and what does that mean for maintenance and cost?
The EEG-1260A Neurofax System and JE-940A EEG Amplifier Unit are explicitly labeled as non-sterile, reusable medical devices, meaning they are intended for repeated use in clinical settings after proper cleaning and maintenance. This design reduces per-procedure costs but requires adherence to manufacturer guidelines for disinfection and upkeep. The LS-940A Photic Stimulator is supplied as part of the system and is not separately classified as reusable or single-use in the provided data.
What regulatory pathways have this device undergone, and how does that affect its use in clinical settings?
The EEG-1260A Neurofax System has undergone FDA 510(k) clearance and EU MDR compliance, confirming its safety and performance for clinical use in neurology settings. The system was determined substantially equivalent to a predicate device by the FDA’s Neurology Advisory Committee (NE), and its classification as a Class II device (per OpenFDA data) reflects its moderate-risk designation. These pathways ensure the device meets stringent regulatory standards for diagnostic accuracy and patient safety.
How should the system be stored, and are there any special handling instructions provided by the manufacturer?
While the data does not specify exact storage conditions, standard medical device protocols apply for the EEG-1260A Neurofax System and its components. The reusable hardware (EEG-1260A and JE-940A) should be stored in a clean, dry environment protected from physical damage or contamination. The manufacturer’s guidelines—though not detailed here—likely include instructions for proper disinfection between uses and secure storage to maintain functionality. Always refer to the manufacturer’s instructions for precise handling.
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: EEG System (1260A) - NIHON KOHDEN GLOBAL, EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE ..., EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG… - FDA.report
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 | K251366 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nihon Kohden Corporation
Sources (2)
- FDA 510(k) K251366 24 fields · synced Oct 6, 2026
- EUDAMED 46f312f1-4f5f-4fb4-9216-ebd3d3d5b4dd 61 fields · synced Jul 15, 2026