MEB-2300A Neuropack Evoked Potential and EMG Measuring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120397 FDA 510(k)
- FDA Product Code
- GWF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1870 FDA 510(k)
- Regulation Number
- 882.1870 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MEB-2300A Neuropack Evoked Potential and EMG Measuring System is an electrical stimulator and evoked response device. It is designed to monitor, record, and display bioelectric signals produced by muscles and nerves, as well as to stimulate peripheral nerves to assist clinicians in the diagnosis and prognosis of neuromuscular conditions.
This device is authorized under FDA 510(k) clearance K120397. It is classified as a Class 2 medical device under regulation number 882.1870.
Frequently asked questions
What is the primary function of the MEB-2300A Neuropack?
The MEB-2300A is designed to monitor, record, and display bioelectric signals produced by muscles and nerves. It also functions as an electrical stimulator for peripheral nerves to assist clinicians in the diagnosis and prognosis of various neuromuscular conditions.
What is the regulatory status of this device?
The MEB-2300A Neuropack is authorized under FDA 510(k) clearance K120397. It is classified as a Class 2 medical device under regulation number 882.1870.
What medical specialty is this device intended for?
This device is categorized under the neurology medical specialty, as it is specifically engineered to measure and stimulate the electrical activity of the nervous and muscular systems for diagnostic purposes.
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: Neuropack X1 (MEB-2300) - Nihon Kohden Europe, Meb-2300a Neuropack Evoked Potential and Emg Measuring System (K120397 ..., Meb-2300a Neuropack Evoked Potential and Emg Measuring System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120397 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden Corp.
Sources (1)
- FDA 510(k) K120397 24 fields · synced Sep 21, 2026