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

    CINE CAMERA CONTROL MODEL PK2037

    K Number: K896615 · Decision Jan 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    11
    Applicant Total
    14
    Review Days
    44

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    Basic Information

    Device Name
    CINE CAMERA CONTROL MODEL PK2037
    K Number
    K896615
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1620
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Perkins Mfg. Co.
    Date Received
    November 21, 1989
    Decision Date
    January 4, 1990
    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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