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

    DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100

    K Number: K080854 · Decision Oct 20, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    7
    Review Days
    207

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    Basic Information

    Device Name
    DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100
    K Number
    K080854
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suntech Medical, Inc.
    Date Received
    March 27, 2008
    Decision Date
    October 20, 2008
    Product Code
    DXQ
    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
    DXQ Blood Pressure Cuff

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