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

    NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01

    K Number: K080175 · Decision Jun 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    4
    Review Days
    137

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    Basic Information

    Device Name
    NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
    K Number
    K080175
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datascope Corp., Patient Monitoring Division
    Date Received
    January 24, 2008
    Decision Date
    June 9, 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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    Other Clearances by Datascope Corp., Patient Monitoring Division

    K Number Device Name
    K123211 A5 ANESTHESIA DELIVERY SYSTEM
    K091834 PASSPORT V MONITOR, MODEL 0998-00-6100
    K091068 ACCUTORR V MONITOR, MODEL 0998-00-2000