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

    AXISONIC II

    K Number: K810697 · Decision Jul 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    28
    Applicant Total
    18
    Review Days
    119

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    Basic Information

    Device Name
    AXISONIC II
    K Number
    K810697
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Teknar, Inc.
    Date Received
    March 16, 1981
    Decision Date
    July 13, 1981
    Product Code
    HDR
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HDR Cap, Cervical

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