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510(k) Data Aggregation

    K Number
    K112173
    Device Name
    SPEACELABS MULTIGAS MODULE
    Manufacturer
    SPACELABS HEALTHCARE
    Date Cleared
    2011-10-05

    (69 days)

    Product Code
    CBR, CBQ, CBS, CCK, CCL, NHO, NHP, NHQ
    Regulation Number
    868.1700
    Why did this record match?
    Product Code :

    CBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spacelabs Multigas Module, Model 92518 (Model 92518) is intended to provide a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits. The multigas module is capable of automatically identifying which anesthetic agent(s) is being administered. The 92518 Multigas Module is intended to be used with and controlled by a Spacelabs Healthcare Ultraview-family monitor. The 92518 Multigas Module is intended to be used for monitoring all hospitalized patients, under the direction of qualified medical personnel. Although the 92518 Multigas Module alarms when the duration between breaths exceeds user defined limits, it is not intended to be a primary diagnostic apnea monitor and/or recording device.
    Device Description
    The Spacelabs Multigas Module, Model 92518 (Model 92518) is an easy-to-use modular unit in the Spacelabs Healthcare Ultraview-family of monitors (Ultraview). The Module 92518 is inserted into a bay within an Ultraview monitor. The Ultraview monitor is then used to control the Model 92518, and provide the user interface for the Model 92518. The Module 92518 is a sidestream analyzer intended to provide a measurement of the following parameters: Carbon Dioxide (CO2); Oxygen (O2) and Nitrous Oxide (N2O); Anesthetic agents including Desflurane; Enflurane; Halothane; Isoflurane; and Sevorflurane; Respiratory rate; and Calculated MAC and age-dependent MAC values. The Spacelabs Ultraview monitors display information from the Module 92518 and are the user interface for the Model 92518. Ultraview monitors provide a number display for the anesthetic agent concentrations and respiratory rate, and a capnograph waveform display for O2 and CO2. The Module 92518 automatically identifies which anesthetic agent or mixture of anesthetic agents is present, and measures the concentration of the identified agent(s). An alarm is issued if a mixture of more than two anesthetic agents is detected. The Module 92518 is intended to be used primarily in the operating room environment
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    K Number
    K053599
    Device Name
    SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
    Manufacturer
    SPACELABS MEDICAL INC.
    Date Cleared
    2006-04-19

    (117 days)

    Product Code
    CBR
    Regulation Number
    868.1700
    Why did this record match?
    Product Code :

    CBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spacelabs Medical Multigas Analyzer Module 91518 (Module 91518) is intended to provide a means of monitoring a variety of gas concentrations and to alert clinical personnel when the concentration of anesthetic agent, oxygen, carbon dioxide or nitrous oxide falls outside of user defined limits. The Module 91518 is capable of automatically identifying which anesthetic agent(s) is being administered. The Module 91518 is intended to be used with, and is controlled by, any Spacelabs Medical monitor, except the SLP100. The Module 91518 is intended for use monitoring all hospitalized patients under the direction of qualified medical personnel. Although the Module 91518 alarms when the duration between breaths exceeds user defined limits, it is not intended to be a primary diagnostic apnea monitor and/or recording device.
    Device Description
    The Spacelabs Medical Multigas Analyzer Module 91518 (Module 91518) is an easy-to-use modular unit in the Spacelabs Medical product family. The Module 91518 is a multigas sidestream analyzer intended to provide a measurement of the following parameters; - CO2 produced by the patient; - . O2 and N2O administered to the patient; - Anesthetic agents administered to the patient which includes: . - Desflurane; - O Enflurane: - Halothane; O - lsoflurane; and O - Sevorflur-ane. - . Respiratory rate of the patient; and - Calculated MAC and age-dependent MAC values. . The Module 91518 automatically identifies which anesthetic agent or mixture of anesthetic agents is present, and measures the concentration of the identified agent(s). An alarm is issued if a mixture of more than two anesthetic agents is dctected. The Module 91518 interfaces with all Spacelabs Medical monitors, except the SLP100. The monitor provides a numeric display for the gas concentrations and respiratory rate, and a waveform display for O2 and CO2. The Module 91518 is intended to be used for monitoring all hospitalized patients under the direction of qualified medical personnel.
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    K Number
    K954962
    Device Name
    SPACELABS MEDICAL MULTIGAS ANALYZER
    Manufacturer
    SPACELABS, INC.
    Date Cleared
    1996-05-31

    (214 days)

    Product Code
    CBR
    Regulation Number
    868.1700
    Why did this record match?
    Product Code :

    CBR

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

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