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

    NAVIGATOR APPLICATIONS SUITE

    K Number: K081941 · Decision Aug 7, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    30
    Review Days
    30

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    Basic Information

    Device Name
    NAVIGATOR APPLICATIONS SUITE
    K Number
    K081941
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GE Healthcare Finland Oy
    Date Received
    July 8, 2008
    Decision Date
    August 7, 2008
    Product Code
    BSZ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSZ Gas-Machine, Anesthesia

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