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510(k) Data Aggregation

    K Number
    K082967
    Device Name
    MORTARA STRESS ECHO BED
    Date Cleared
    2009-03-26

    (171 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL POSITIONING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The M-Stress Echo™ Bed is intended for use in stress echocardiography examination. The M-Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance. The M-Stress Echo™ Bed incorporates an electrocardiograph that records either normal conditions or patterns of arrhythmia and/or rate abnormalities in patients. In addition, the stress echo workstation provides "QRS" complex to a cardiac ultrasound device to be used to capture images (heart beats). either digitally or on videotape, such that each image begins at the time systole begins.
    Device Description
    The Mortara Stress Echo™ Bed is a complete integrated stress echocardiography system. The Mortara Stress Echo™ Bed combines the Stress Echo Bed / Table with an electrocardiograph. The Stress Echo Bed provides an exercise source that delivers programmable, controlled variable resistance, while the ECG provides the patient monitoring and recording. Several models of the Stress Echo Bed/Table are available with features that include height adjustability, Trendelenburg, dual, lateral tilt, and computer controllers.
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    K Number
    K021171
    Device Name
    Q-STRESS ECHO BED
    Date Cleared
    2002-05-08

    (26 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL POSITIONING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Q-Stress Echo™ Bed is intended for use in stress echocardiography examination. The Q-Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance. The Q-Stress Echo™ Bed incorporates an electrocardiograph that records either normal conditions or patterns of arrhythmia and/or rate abnormalities in patients. In addition, the stress echo workstation provides "QRS" complex to a cardiac ultrasound device to be used to capture images (heart beats), either digitally or on videotape, such that each image begins at the time systole begins.
    Device Description
    The Q-Stress Echo™ Bed is a complete integrated stress echocardiography system. The Q-Stress Echo™ Bed combines the Stress Echo™ Bed / Table with an electrocardiograph. The Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance, while the ECG provides the patient monitoring and recording. Several models of the Stress Echo Bed/Table are available with features that include height adjustability, Trendelenburg, dual, lateral tilt, and computer controllers.
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    K Number
    K002822
    Device Name
    VERTEX SYSTEM
    Date Cleared
    2001-01-31

    (142 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL POSITIONING, INC.

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