BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA

    K Number: K912145 · Decision May 5, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    22
    Applicant Total
    46
    Review Days
    392

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    Basic Information

    Device Name
    SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA
    K Number
    K912145
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1200
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    S & W Medico Teknik
    Date Received
    April 9, 1991
    Decision Date
    May 5, 1992
    Product Code
    CCE
    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
    CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

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    Other Clearances by S & W Medico Teknik

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    K913013 TCPO2 9260 MODULE - SYSTEM ATHENA
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    K930134 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT
    K923418 9293/1 INTERFACE MODULE
    K911611 SYSTEM ATHENA, MODIFICATION
    K922314 VENTILATOR INTERFACE 9291/4
    K912815 NIBP 9225 COMBI
    K912000 TYPE INTERFACE 9271/1 INCUBATOR/WARMER
    K912183 TYPE 9050/NEO
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