Cervello Bio-Potential Signal Acquistion System Product Family
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122196 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 Cervello Bio-Potential Signal Acquisition System is a Full-Montage Standard Electroencephalograph, designed for recording and analyzing bio-potential signals from the brain. It functions as a multi-channel amplifier and acquisition platform, enabling high-resolution monitoring of neural activity for clinical and research applications in neurology.
This system is supplied as a reusable medical device, intended for use in clinical settings such as hospitals and research laboratories. It supports configurations ranging from 64 to 256 channels, depending on hardware and software combinations, and operates under FDA 510(k) clearance (K122196) under regulation 882.1400. The device is classified as Class II and requires adherence to standard electroencephalographic safety and performance standards.
Frequently asked questions
What clinical applications is the Cervello Bio-Potential Signal Acquisition System primarily used for?
The Cervello system is designed for recording and analyzing brain bio-potential signals, making it ideal for clinical and research applications in neurology. It supports high-resolution monitoring of neural activity, which is useful for diagnosing and studying conditions like epilepsy, sleep disorders, or brain function mapping. Its multi-channel capabilities (64–256 channels) enable detailed EEG assessments in hospitals and research labs.
How many channels does the Cervello system support, and how does that affect its use?
The Cervello system supports configurations ranging from 64 to 256 channels, depending on the hardware and software combination selected. This flexibility allows clinicians to choose the appropriate channel count for their specific needs—whether for standard EEG monitoring (e.g., 64 channels) or high-density mapping (e.g., 256 channels) in research or complex diagnostic cases. The higher channel counts enable more granular neural signal acquisition.
Is the Cervello system reusable, and what maintenance considerations should be noted?
Yes, the Cervello system is designed as a reusable medical device, intended for clinical settings like hospitals and research labs. Since it is reusable, proper cleaning, calibration, and adherence to manufacturer guidelines are essential to maintain performance and ensure patient safety. The system’s durability and modular design support long-term use, but routine maintenance is required to uphold its electrophysiological accuracy.
What regulatory pathway was followed for FDA clearance of this device?
The Cervello system received FDA 510(k) clearance (K122196) under the traditional review pathway, classified as Class II. The submission was reviewed by the Neurology (NE) Advisory Committee and determined to be substantially equivalent to a predicate device. This clearance falls under regulation 882.1400, which governs full-montage standard electroencephalographs, ensuring compliance with safety and performance standards for EEG devices.
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: Cervello Bio-potential Signal Acquistion System Product Family, CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY 510 (k ..., PDF kK22,19 U - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122196 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blackrock Neuromed, Llc
Sources (1)
- FDA 510(k) K122196 24 fields · synced Sep 19, 2026