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

    CAP-35B III/CINE 275

    K Number: K971128 · Decision Apr 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    76
    Applicant Total
    6
    Review Days
    32

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    Basic Information

    Device Name
    CAP-35B III/CINE 275
    K Number
    K971128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jamieson Film Co.
    Date Received
    March 27, 1997
    Decision Date
    April 28, 1997
    Product Code
    IXR
    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
    IXR Table, Radiographic, Tilting

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