(265 days)
The microEEG® system is a portable 26 channel digital electroencephalography (EEG) collection and wireless data transfer device that is designed for use in hospitals and other medical environments. The system digitizes analogue EEG signals collected by 3rd party electrodes, amplifies them, and uses Bluetooth® wireless connectivity to transfer the EEG data to a dedicated host computer.
It is important to note that the microEEG® system collects and manages EEG data only. The system does not analyze or interpret EEG data in any manner. Rather, all such EEG analysis and interpretation is performed by a medical professional/clinician.
The microEEG® system is a portable 26 channel digital electroencephalography (EEG) collection and wireless data transfer device that is designed for use in hospitals and other medical environments. The system digitizes analogue EEG signals collected by 3rd party electrodes, amplifies them, and uses Bluetooth® wireless connectivity to transfer the EEG data to a dedicated host computer.
This document is a 510(k) clearance letter for the Bio-Signal Group Corporation's MicroEEG System. It primarily addresses the regulatory approval of the device and its indications for use. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it explicitly states, "The system does not analyze or interpret EEG data in any manner. Rather, all such EEG analysis and interpretation is performed by a medical professional/clinician."
Therefore, I cannot provide the requested information from this document.
For a device that does analyze or interpret data, the ideal source for this information would be a summary of safety and effectiveness data (SSED) or a clinical study report included in the 510(k) submission, which is not provided in these excerpts.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).