LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K121141
    Device Name
    TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
    Manufacturer
    TENSYS MEDICAL SYSTEMS, INC
    Date Cleared
    2012-05-15

    (29 days)

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

    TENSYS MEDICAL SYSTEMS, 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
    TL200 T-Line® Non-invasive Blood Pressure Monitoring System
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1