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

    P.R.M. 80

    K Number: K810590 · Decision Apr 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    37

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    Basic Information

    Device Name
    P.R.M. 80
    K Number
    K810590
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    T.E.M. Instruments , Ltd.
    Date Received
    March 4, 1981
    Decision Date
    April 10, 1981
    Product Code
    IZW
    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
    IZW Collimator, Automatic, Radiographic

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