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

    MPQ-42

    K Number: K934944 · Decision Dec 15, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    9
    Applicant Total
    11
    Review Days
    58

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    Basic Information

    Device Name
    MPQ-42
    K Number
    K934944
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1870
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elema-Schonander, Inc.
    Date Received
    October 18, 1993
    Decision Date
    December 15, 1993
    Product Code
    IZP
    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
    IZP Programmer, Changer, Film/Cassette, Radiographic

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