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

    DIGITAL CRADLE

    K Number: K840463 · Decision Feb 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    8
    Applicant Total
    9
    Review Days
    19

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    Basic Information

    Device Name
    DIGITAL CRADLE
    K Number
    K840463
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1830
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Spectrum X-Ray Corp.
    Date Received
    February 2, 1984
    Decision Date
    February 21, 1984
    Product Code
    KXH
    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
    KXH Cradle, Patient, Radiologic

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