BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM

    K Number: K020537 · Decision Aug 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    2
    Review Days
    177

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    Basic Information

    Device Name
    TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM
    K Number
    K020537
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tensys Medical, Inc.
    Date Received
    February 19, 2002
    Decision Date
    August 15, 2002
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by Tensys Medical, Inc.

    K Number Device Name
    K022783 TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM