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

    PROWESS 2000

    K Number: K924240 · Decision May 17, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    2
    Review Days
    266

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    Basic Information

    Device Name
    PROWESS 2000
    K Number
    K924240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Small Systems Group, Inc.
    Date Received
    August 24, 1992
    Decision Date
    May 17, 1993
    Product Code
    IYE
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYE Accelerator, Linear, Medical

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    Other Clearances by Small Systems Group, Inc.

    K Number Device Name
    K884261 PROWESS 2000