(90 days)
The "Ambulatory EEG" is a battery powered electroencephalograph which is intended to acquire and store electroencephalographic signals (electical signals of the brain).
When connected, as part of a system, to the NeuroWorks [FDA 510(k) # K980214], the system is also intended to display and archive there signals.
The "Ambulatory EEG" is a battery powered electroencephalograph which is intended to acquire and store electroencephalographic signals (electical signals of the brain).
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The documents are primarily an FDA 510(k) clearance letter and an "Indications For Use" statement for the Excel Ambulatory EEG device.
The documents confirm the device's clearance and intended use but do not include any performance data, acceptance criteria, study methodologies, or results.
Therefore, I cannot provide the requested information in the format specified.
§ 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).