# K122196: Cervello Bio-Potential Signal Acquistion System Product Family

- Pathway: 510(k) (Traditional)
- Applicant: Blackrock Neuromed, LLC
- Decided: May 2, 2013 after 282 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K884937 (1989). 28 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090957: Blackrock Neuroport Biopotential Signal Processing System, I2s Micro Implantable Systems, LLC (2009) Summary page 2.
- K071782: Micromed Brain Spy Plus, Embia Titanium Devices, Micromed S.P.A. (2008) Summary page 2.
- K000963: DA Vinchi Eeg and Emg/EP Systems, Airsep Corp. (2000) Summary page 2.

## Most influential descendants
- K133995: Neuron-Spectrum-4/P with Neuron-Spectrum.Net Software (2015), 1 descendant of its own
- K220254: Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (2022), 0 descendants of its own
- K171384: Micromed BRAIN QUICK system (2018), 0 descendants of its own

## Indications for use
The Blackrock NeuroMed Cervello Bio-Potential Signal Acquisition Product Family contains the following configurations: Ambulatory Up to 64 channels with one Cervello hardware device (Amplifier) using the Cervello software. The device is intended to acquire and store physiological signals for EEG and/or PSG, and to transfer the data to separate polysomnographic analysis software. The devices are intended to be used by physicians, technicians and other medical professions that are trained in EEG and/or PSG. The Cervello Ambulatory System does not make any judgment of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic. Basic Up to 64 channels with one Cervello hardware device (Amplifier) and up to 128 channels by cascading 2 Cervello devices using the Cervello software. The device is intended to acquire and store physiological signals for EEG and/or PSC, and to transfer the data to separate polysomnographic analysis software. The devices are intended to be used by physicians, technicians and other medical professions that are trained in EEC and/or PSG. The Cervello Basic System does not make any judgment of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic. Elite Up to 128 with one Neuroport Bio-Potential Recording Systems and up to 256 by cascading two Neuroport systems using the Central and/or Cervello software. The system supports recording, processing and display of bio-potential signals from user-supplied electrodes. Bio-potential signals include: Electrocorticography (ECoC), electroencephalography (EEC), electromyography (EMC), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP). Intended users include Physicians, technicians, clinicians or other medical professionals that are trained in bio-potential and/or EEC recording. The Cervello Elite System does not make any judgment of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

Source page: https://510kreport.com/device/K122196
Methodology: https://510kreport.com/methodology