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

    DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES

    K Number: K080366 · Decision Jun 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    2
    Review Days
    118

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    Basic Information

    Device Name
    DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES
    K Number
    K080366
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zefon Intl.
    Date Received
    February 12, 2008
    Decision Date
    June 9, 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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    Other Clearances by Zefon Intl.

    K Number Device Name
    K082630 VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES