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

    ELITY 70 X-RAY

    K Number: K043136 · Decision Jan 6, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    189
    Applicant Total
    1
    Review Days
    55

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    Basic Information

    Device Name
    ELITY 70 X-RAY
    K Number
    K043136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dental X-Ray E.U.
    Date Received
    November 12, 2004
    Decision Date
    January 6, 2005
    Product Code
    EHD
    Advisory Committee
    Dental
    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
    EHD Unit, X-Ray, Extraoral With Timer

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