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

    IMAGE-X 70 INTRAORAL X-RAY SYSTEM

    K Number: K930761 · Decision May 25, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    41
    Applicant Total
    13
    Review Days
    102

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    Basic Information

    Device Name
    IMAGE-X 70 INTRAORAL X-RAY SYSTEM
    K Number
    K930761
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1810
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Afp Imaging Corp.
    Date Received
    February 12, 1993
    Decision Date
    May 25, 1993
    Product Code
    EAP
    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
    EAP Unit, X-Ray, Intraoral

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