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510(k) Data Aggregation

    K Number
    K053112
    Device Name
    BIOSIGN
    Manufacturer
    OXFORD BIOSIGNALS LIMITED
    Date Cleared
    2006-01-31

    (88 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OXFORD BIOSIGNALS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioSign™ is an accessory to a multi-parameter patient monitor (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine. BioSign™ provides the clinician with a trend graph of the patient status index based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The patient status index is a single measure of the patient's condition and represents how different the patient's vital signs are with respect to normality. BioSign™ is an adjunct to and is not intended to replace vital signs monitoring.
    Device Description
    BioSign™ is a software accessory to standard multiple parameter physiological patient monitors (bedside or ambulatory) or clinical information systems. It operates on a standard medical grade computer. BioSign™ is a software device embedded in a standard medical grade computer that through advanced signal processing can combine physiological signals in order to produce a single graph representation of patient condition. BioSign™ is a computerized analysis system that can accept multiple channels of physiological data (for example heart rate, respiratory rate, temple viauncis of pressure and oxygen saturation as inputs). Through advanced signal procession, BioSign can identify changes in patient status.
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    OXFORD BIOSIGNALS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K021485
    Device Name
    BIOSOMNIA
    Manufacturer
    OXFORD BIOSIGNALS LIMITED
    Date Cleared
    2002-09-11

    (126 days)

    Product Code
    OMC, OLV
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    OXFORD BIOSIGNALS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oxford BioSignals BioSomnia is a single channel ambulatory EEG with a software package designed for use as an adjunct for the physician in their diagnosis of sleep disorders and to quantify sleep and wakefulness on a second by second basis. The device is designed to be used overnight in the patient's home environment to assist the physician in diagnosing sleep disorders.
    Device Description
    a single channel ambulatory EEG with a software package
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    K Number
    K002622
    Device Name
    BIOSLEEP
    Manufacturer
    OXFORD BIOSIGNALS LIMITED
    Date Cleared
    2000-10-23

    (61 days)

    Product Code
    OLZ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    OXFORD BIOSIGNALS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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