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510(k) Data Aggregation

    K Number
    K042309
    Device Name
    BIOSOMNIA-V3
    Manufacturer
    OXFORD BIOSIGNALS LIMITED
    Date Cleared
    2004-09-08

    (14 days)

    Product Code
    OMC,OLV
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOSOMNIA-V3

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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.

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