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

    SUCTION SAFETY DEVICE

    K Number: K960937 · Decision Jun 5, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    89

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    Basic Information

    Device Name
    SUCTION SAFETY DEVICE
    K Number
    K960937
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R D Intl.
    Date Received
    March 8, 1996
    Decision Date
    June 5, 1996
    Product Code
    MJJ
    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
    MJJ Cpb Check Valve, Retrograde Flow, In-Line

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    Other Clearances by R D Intl.

    K Number Device Name
    K960312 RDI CARDIAC INSULATION PAD