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

    MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA

    K Number: K915633 · Decision Jun 29, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    46
    Review Days
    609

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    Basic Information

    Device Name
    MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA
    K Number
    K915633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    S & W Medico Teknik
    Date Received
    October 29, 1991
    Decision Date
    June 29, 1993
    Product Code
    FLL
    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
    FLL Continuous Measurement Thermometer

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    Other Clearances by S & W Medico Teknik

    K Number Device Name
    K940933 9267 SPO2 ATHENA MODULE
    K913013 TCPO2 9260 MODULE - SYSTEM ATHENA
    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
    K912145 SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA
    Search all 46 clearances from S & W Medico Teknik →