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    K Number
    K022783
    Device Name
    TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM
    Manufacturer
    TENSYS MEDICAL, INC.
    Date Cleared
    2002-11-19

    (89 days)

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

    TENSYS MEDICAL, 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
    The TL100 Tensymeter is a non-invasive blood pressure monitor that utilizes a single patient use non-invasive pressure sensor placed on the wrist, over the radial artery, and an electronic interface module. The device uses proprietary algorithms to analyze the radial artery pressure and display diastolic, systolic, mean blood pressure, pulse rate and a pressure waveform.
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    K Number
    K020537
    Device Name
    TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM
    Manufacturer
    TENSYS MEDICAL, INC.
    Date Cleared
    2002-08-15

    (177 days)

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

    TENSYS MEDICAL, 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 continuously 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
    The TL10 Tensymeter is a non-invasive blood pressure monitor that utilizes a single patient use non-invasive pressure sensor placed on the wrist, over the radial artery, and an electronic interface module. The device uses proprietary algorithms to analyze the radial artery pressure and display diastolic, systolic, mean blood pressure, pulse rate and a pressure waveform.
    Ask a Question

    Ask a specific question about this device

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