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    K Number
    K042745
    Device Name
    LIFESCREEN APNEA
    Manufacturer
    DEL MAR REYNOLDS MEDICAL, INC.
    Date Cleared
    2005-01-19

    (107 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEL MAR REYNOLDS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.
    Device Description
    Lifescreen Apnea is a software option for the LifeScreen ECG Holter scanning software. The Lifescreen Apnea option is a software addition only - no hardware changes are involved.
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