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510(k) Data Aggregation

    K Number
    K123446
    Device Name
    TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
    Manufacturer
    United States GTM Medical Devices, Inc.
    Date Cleared
    2012-12-07

    (29 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    United States GTM Medical Devices, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended for use by medically trained personnel in a clinical setting to continually monitor and display diastolic, systolic, and mean blood pressures and pulse rate. The device is intended for use on adult patients with a palpable pulse.
    Device Description
    Not Found
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