BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    BIG BEN

    K Number: K942650 · Decision Aug 15, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    420
    Registration Numbers
    420
    Same Product Code
    1186
    Applicant Total
    4
    Review Days
    76

    Basic Information

    Device Name
    BIG BEN
    K Number
    K942650
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    RUD RIESTER GMBH & CO KG
    Date Received
    May 31, 1994
    Decision Date
    August 15, 1994
    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 RUD RIESTER GMBH & CO KG

    K Number Device Name
    K944337 VARIOUS STETHOSCOPES
    K942649 MINIMUS I; MINIMUS III, SANAPHON
    K943461 VARIOUS TYPES OF MERCURIALS