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

    ANEROID AND MERCURIAL SPHYGMOMANOMETERS

    K Number: K962655 · Decision Jan 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    39
    Review Days
    203

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    Basic Information

    Device Name
    ANEROID AND MERCURIAL SPHYGMOMANOMETERS
    K Number
    K962655
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Diagnostic Corp.
    Date Received
    July 8, 1996
    Decision Date
    January 27, 1997
    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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