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

    ACIST GENTOO CONTRAST INJECTION SYSTEM

    K Number: K020892 · Decision Jan 27, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    204
    Applicant Total
    7
    Review Days
    314

    Basic Information

    Device Name
    ACIST GENTOO CONTRAST INJECTION SYSTEM
    K Number
    K020892
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ACIST MEDICAL SYSTEMS
    Date Received
    March 19, 2002
    Decision Date
    January 27, 2003
    Product Code
    DXT
    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
    DXT Injector And Syringe, Angiographic

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