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

    ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000

    K Number: K000013 · Decision Mar 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    7
    Review Days
    85

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    Basic Information

    Device Name
    ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
    K Number
    K000013
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acist Medical Systems
    Date Received
    January 3, 2000
    Decision Date
    March 28, 2000
    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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