Nihon Kohden Neuropack Sigma Meb-5500a Evoked Response & Emg Measuring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K950208 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 Neuropack Sigma MEB-5500A is an evoked response and EMG measuring system. It functions as an electrical stimulator designed to apply electrical stimuli to a patient via skin electrodes to measure the resulting evoked response.
This device is categorized under neurology and is subject to FDA 510k authorization under K950208. It is classified as a class 2 device for clinical use.
Frequently asked questions
What is the primary function of the Neuropack Sigma MEB-5500A?
This device is an evoked response and EMG measuring system designed for clinical neurology. It functions as an electrical stimulator that applies stimuli to a patient via skin electrodes to measure the resulting evoked response.
What is the regulatory status of this device?
The Neuropack Sigma MEB-5500A is subject to FDA 510k authorization under K950208. It is classified as a class 2 device for clinical use.
Which medical specialty is this system intended for?
This device is categorized under the field of neurology. It is designed to assist clinicians in performing evoked response and EMG measurements as part of neurological assessments.
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: Nihon Kohden Neuropack Sigma Meb-5500a Evoked Response & Emg Measuring ..., Nihon Kohden Neuropack Sigma Meb-5500a Evoked Response & Emg Measuring ..., PDF K950208 Nihon Kohden Neuropack Sigma Meb-5500a Evoked Response & Emg ..., fda.innolitics.com, EMG Neuropack Sigma, MEB-5500 (Nihon Kohden) - Diagramma AG
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K950208 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden America, Inc.
Sources (1)
- FDA 510(k) K950208 24 fields · synced Sep 21, 2026