(14 days)
Oxford BioSignals BioSomnia V3 is a three channel ambulatory device providing signal amplification of two channels of EEG and one of EMG and connections to external devices for subsequent EEG / EMG signal display, storage and analysis. The device is designed to be used overnight in the patient's home environment to assist the physician in diagnosing sleep disorders.
Oxford BioSignals BioSomnia V3 is a three channel ambulatory device providing signal amplification of two channels of EEG and one of EMG and connections to external devices for subsequent EEG / EMG signal display, storage and analysis.
This document is a 510(k) clearance letter for the BioSomnia V3 device. It states the device's indications for use but does not contain any information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on specific performance data or a clinical study demonstrating predefined acceptance criteria.
§ 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).