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

    CCD CAMERA, MODEL PKP-06000-000

    K Number: K024085 · Decision Mar 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    CCD CAMERA, MODEL PKP-06000-000
    K Number
    K024085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1620
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Perkins Electronics Co.
    Date Received
    December 11, 2002
    Decision Date
    March 11, 2003
    Product Code
    IZJ
    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
    IZJ Camera, X-Ray, Fluorographic, Cine Or Spot

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