Neuro Omega System, NeuroSmart System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220553 FDA 510(k)
- FDA Product Code
- GZL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1330 FDA 510(k)
- Regulation Number
- 882.1330 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Neuro Omega System, NeuroSmart System is an Electrode, Depth device, classified under the medical specialty of Neurology. It is designed to provide data for neuroscience research and functional neurology and neurosurgery. The system includes advanced target localization capabilities and automatic navigation.
The Neuro Omega System, NeuroSmart System is supplied with a range of features, including Matlab tool software and Ethernet streaming. It is available with a support package, including phone and Skype support. The device has been authorized with an FDA 510K clearance, with a regulation number of 882.1330 and a product code of GZL.
Manufacturer's product page: Neuro Omega
Frequently asked questions
What is the Neuro Omega System used for?
The Neuro Omega System is designed to provide data for neuroscience research and functional neurology and neurosurgery, utilizing its advanced target localization capabilities and automatic navigation.
What features are included with the Neuro Omega System?
The system includes Matlab tool software and Ethernet streaming, and is available with a support package, including phone and Skype support.
What regulatory clearance has the Neuro Omega System received?
The Neuro Omega System has received FDA 510K clearance, with a regulation number of 882.1330 and a product code of GZL.
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: NeuroSmart - Alpha Omega Eng, Nero Omega - Alpha Omega Eng, Neurologische Erkrankungen: Arten, Symptome - netDoktor.de, Neuro Omega | PDF | Neurology | Electromagnetic Compatibility
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220553 | Class II | Active |
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Manufacturer
- Manufacturer
- Alpha Omega Engineering Ltd
- FDA Applicant
- Alpha Omega Engineering , Ltd.
Sources (1)
- FDA 510(k) K220553 24 fields · synced Sep 21, 2026