BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MD100 & MM150

    K Number: K963913 · Decision Oct 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    34
    Applicant Total
    12
    Review Days
    373

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    Basic Information

    Device Name
    MD100 & MM150
    K Number
    K963913
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1960
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Konica Medical Corp.
    Date Received
    September 30, 1996
    Decision Date
    October 8, 1997
    Product Code
    EAM
    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
    EAM Screen, Intensifying, Radiographic

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