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510(k) Data Aggregation

    K Number
    K020365
    Device Name
    3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
    Manufacturer
    3T MEDICAL SYSTEMS, LLC.
    Date Cleared
    2002-05-03

    (88 days)

    Product Code
    KRI
    Regulation Number
    870.4200
    Why did this record match?
    Product Code :

    KRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3T Myocardial Needle Temperature Probes are indicated for use in the routine monitoring of temperature during open-heart surgery and is intended for insertion into the myocardium.
    Device Description
    Not Found
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    K Number
    K992635
    Device Name
    INTERFACE MODULE IDDD
    Manufacturer
    STOECKERT INSTRUMENTE
    Date Cleared
    1999-12-20

    (136 days)

    Product Code
    KRI, DTQ
    Regulation Number
    870.4200
    Why did this record match?
    Product Code :

    KRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stöckert S3 heart lung machine and the SC heart lung system are integrated heart lung machines for cardiopulmonary bypass. The Interface Module IDDD provides serial data output from the Stöckert S3 and SC Heart Lung Machines for recording on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The output protocol provides a complete overview of all relevant data obtained from the heart lung machine as well as from external devices. The serial output data are intended for procedure documentation, and are not intended for making clinical decisions for diagnosis.
    Device Description
    The Stöckert Interface Module IDDD is an addition to the Stöckert S3 heart lung machine (K950990) and the SC heart lung system (K982014), which were both previously cleared for marketing. The Interface Module IDDD provides serial data output from the Stöckert S3 and SC Heart Lung Machines for recording data on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The Interface Module IDDD is installed into the Electronics and Power Supply Pack (E/P) of the S3 or the Sensor Module Rack of the SC. A CAN bus system manages the data transfer.
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    K Number
    K990512
    Device Name
    STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS
    Manufacturer
    STOECKERT INSTRUMENTE
    Date Cleared
    1999-11-23

    (278 days)

    Product Code
    KRI
    Regulation Number
    870.4200
    Why did this record match?
    Product Code :

    KRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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