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

    MODEL 1000 APC-ANGIOPLASTY PRESSURE

    K Number: K841493 · Decision Jun 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    2
    Review Days
    62

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    Basic Information

    Device Name
    MODEL 1000 APC-ANGIOPLASTY PRESSURE
    K Number
    K841493
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    E.A. Fischione Instrument Mfg.
    Date Received
    April 10, 1984
    Decision Date
    June 11, 1984
    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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    Other Clearances by E.A. Fischione Instrument Mfg.

    K Number Device Name
    K853136 MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)