BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    DENSICOMP 250

    K Number: K904587 · Decision Jan 24, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    107

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    Basic Information

    Device Name
    DENSICOMP 250
    K Number
    K904587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    L. Keroack Co.
    Date Received
    October 9, 1990
    Decision Date
    January 24, 1991
    Product Code
    KPW
    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
    KPW Device, Beam Limiting, X-Ray, Diagnostic

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