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

    MED-TRON SPECT IMAGING TABLE

    K Number: K952701 · Decision Jul 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    28
    Applicant Total
    9
    Review Days
    23

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    Basic Information

    Device Name
    MED-TRON SPECT IMAGING TABLE
    K Number
    K952701
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Med-Tron Products, Inc.
    Date Received
    June 13, 1995
    Decision Date
    July 6, 1995
    Product Code
    IZZ
    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
    IZZ Table, Radiographic, Non-Tilting, Powered

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