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

    MITAKA POINT SETTER

    K Number: K991989 · Decision Aug 27, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    92
    Applicant Total
    2
    Review Days
    74

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    Basic Information

    Device Name
    MITAKA POINT SETTER
    K Number
    K991989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1480
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mitaka USA, Inc.
    Date Received
    June 14, 1999
    Decision Date
    August 27, 1999
    Product Code
    GWG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWG Endoscope, Neurological

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    Other Clearances by Mitaka USA, Inc.

    K Number Device Name
    K984355 POINT SETTER