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

    HAND HELD DENTAL X-RAY DEVICE

    K Number: K934818 · Decision Jan 24, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    5
    Review Days
    109

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    Basic Information

    Device Name
    HAND HELD DENTAL X-RAY DEVICE
    K Number
    K934818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dept. of the Army
    Date Received
    October 7, 1993
    Decision Date
    January 24, 1994
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

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