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

    NAVIGATOR-MP CATHETER LOCATION INSTRUMENT

    K Number: K940385 · Decision Jun 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    5
    Review Days
    127

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    Basic Information

    Device Name
    NAVIGATOR-MP CATHETER LOCATION INSTRUMENT
    K Number
    K940385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Navion Biomedical Corp.
    Date Received
    January 26, 1994
    Decision Date
    June 2, 1994
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Navion Biomedical Corp.

    K Number Device Name
    K983476 BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES
    K973057 1.4 FR MAPCATH SENSOR STYLET
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