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

    DUO1 and DUO2

    K Number: K241649 · Decision Jul 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    205
    Applicant Total
    1
    Review Days
    28

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    Basic Information

    Device Name
    DUO1 and DUO2
    K Number
    K241649
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zinnovi, Inc.
    Date Received
    June 7, 2024
    Decision Date
    July 5, 2024
    Product Code
    MUH
    Advisory Committee
    Dental
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MUH System, X-Ray, Extraoral Source, Digital

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