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

    DYNATRON 2000

    K Number: K880912 · Decision Mar 15, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    14
    Applicant Total
    24
    Review Days
    12

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    Basic Information

    Device Name
    DYNATRON 2000
    K Number
    K880912
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.1615
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Dynatronics Corp.
    Date Received
    March 3, 1988
    Decision Date
    March 15, 1988
    Product Code
    IKE
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IKE Transducer, Miniature Pressure

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