NeXus 10 MK3
Mind Media Europe B.V. · Model 1.0 · UDI-DI 08719481550110
Description
The NeXus | 10 MK3 is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/access professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MK3 is not intended for use in diagnosis, nor in critical and/or life supporting applications. The NeXus 10 MK3 is intended for use on humans. The NeXus 10 MK3 is intended to be used with approved NeXus 10 accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus 10 and may require interpretation by user or application software.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-11 | RONAN MEDICAL LLC | Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended. |
| 2017-07-07 | Ondamed Inc | The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has |
| 2015-10-01 | Powers Medical Devices, LLC | PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k). |
| 2012-11-15 | EEG Info | EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices. |
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