Identifiers
- 510(k) Number
- K014147 FDA 510(k)
- FDA Product Code
- GWQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1400 FDA 510(k)
- Regulation Number
- 882.1400 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 80 CHANNEL EEG device is a fully-featured neurology registration-grade electroencephalograph (EEG) designed for comprehensive brain signal analysis. Developed in collaboration with Xltek, this device offers unparalleled accuracy and reliability in measuring brain activity. With its state-of-the-art technology and robust testing procedures, the 80 CHANNEL EEG has been deemed substantially equivalent to other industry-standard devices. Registered with Health Canada, this device is available for purchase by medical professionals seeking high-quality diagnostic tools.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K014147 | Class II | Active |
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Manufacturer
- Manufacturer
- Xltek
Sources (1)
- FDA 510(k) K014147 24 fields · synced Jul 21, 2026