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510(k) Data Aggregation

    K Number
    K994188
    Device Name
    MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
    Manufacturer
    AGILENT TECHNOLOGIES, GMBH
    Date Cleared
    2000-05-19

    (158 days)

    Product Code
    CBQ, CBS
    Regulation Number
    868.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    AGILENT TECHNOLOGIES, GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The M1026A Anesthesia gas Module is intended to measure and monitor anesthesia gas contents in the ventilation circuitry of a patient and to provide this data to health care professionals in form readings, waves and alarms, via the Component Monitoring System, for the support of clinical decision making. The device is indicated for use in health care facilities by health care professionals whenever there is a need for adult, pediatric and neonate patient anesthesia gas monitoring.
    Device Description
    The above device operates with Agilent Technologies Anesthesia Component Monitoring System (ACMS) and the Viridia 24 Agilent Technologies Model 1204A through a digital interface (RS232). The monitoring system is known as the Model M1166A Component Monitoring System (CMS). When coupled with the above ACMS, the device will measure and display respiratory gases and anesthetic agents of ventilated patients. The device will signal physiological alarms and document deviations when preset limits are exceeded. An INOP ("inoperative") alarm is triggered and a message is displayed in the event of malfunction, lack of detectable breath, power disconnects, and other inoperative states.
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    K Number
    K000822
    Device Name
    AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR
    Manufacturer
    AGILENT TECHNOLOGIES, GMBH
    Date Cleared
    2000-04-06

    (23 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    AGILENT TECHNOLOGIES, GMBH

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