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

    NAVIGATOR APPLICATIONS SUITE

    K Number: K102389 · Decision Jun 10, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    186
    Applicant Total
    19
    Review Days
    291

    Basic Information

    Device Name
    NAVIGATOR APPLICATIONS SUITE
    K Number
    K102389
    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
    August 23, 2010
    Decision Date
    June 10, 2011
    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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