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510(k) Data Aggregation

    K Number
    K101602
    Device Name
    VITAL SIGNS MONITOR
    Manufacturer
    CRITICARE SYSTEMS, INC.
    Date Cleared
    2010-09-01

    (85 days)

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

    CRITICARE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor. The monitored parameters are: 1. ECG 2. Noninvasive Blood Pressure (NIBP) 3. Invasive Blood Pressure (IBP) 4. Temperature 5. Respiratory Gases 6. Anesthetic Agent Gases 7. Respiratory Rate 8. Pulse Oximetry (SpO2) 9. Arrhythmia and ST Analysis of the ECG waveforms
    Device Description
    The 9100 monitor measures and displays real time physiological data of the patient, including a graphical plethysmogram and numerical data. The 9100 is a modular system and can be used to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP, Temperature, Respiratory Gases, Anesthetic Agent Gases and SpO2. Arrhythmia and ST Segment analysis of the ECG waveforms is also offered. For all these vital parameters, the 9100 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
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    K Number
    K091050
    Device Name
    506CN PATIENT MONITOR
    Manufacturer
    CRITICARE SYSTEMS, INC.
    Date Cleared
    2009-05-27

    (44 days)

    Product Code
    DRT, DQA
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRITICARE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
    Device Description
    The 506CN monitor measures and displays real time physiological data of the patient, including a graphical plethysmogram and numerical data. The 506CN can be used to monitor one or more of the following parameters: Noninvasive BP (NIBP) and SpO2. For all these vital parameters, the 506CN will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
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    K Number
    K042569
    Device Name
    8600 VITAL SIGNS MONITOR
    Manufacturer
    CRITICARE SYSTEMS, INC.
    Date Cleared
    2004-09-29

    (8 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRITICARE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
    Device Description
    The 8600 monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 8600 can be configured to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP (IBP), SpOz, Temperature, Respiration, CO2, Nominvasive BP (NIDF), Invasive BP Agenta, For all the samini, CO2, N2O, O2 and Halogenated Anesthetic Agents. For all these vital parameters, the 8600 will be capable of limit alams and alerts, printing of strip chart recordings and storing trends for retrospective review.
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    K Number
    K030613
    Device Name
    VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
    Manufacturer
    CRITICARE SYSTEMS, INC.
    Date Cleared
    2003-04-17

    (50 days)

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

    CRITICARE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarns and patient data analysis will be available to the care provider from the monitor.
    Device Description
    The 8100 monitor interprets and displays real time physiological data of the patient including waveforms and numerical data. The 8100 can be custom configured to monitor ECG, Noninvasive BP (NIBP), Invasive BP (IBP), S.O2, Temperature, Respiration, CO2, N.O. O2 and Halogenated Anesthetic Agents. Arrhythmia Detection and ST Analysis software from Brentwood Medical has been incorporated into the 8100 system and uses the extant ECG hardware inputs and microprocessor to enable these capabilities. All user interface elements are provided by the existing 8100 monitor. For each patient vital parameter, the 8100 will be capable of providing limit alarms and alerts, printing of strip chart recordings and storing data trends for retrospective review.
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    K Number
    K022435
    Device Name
    507EL VITAL SIGNS MONITOR
    Manufacturer
    CRITICARE SYSTEMS, INC.
    Date Cleared
    2002-08-14

    (20 days)

    Product Code
    DRT
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRITICARE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
    Device Description
    The 507EL monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 507EL can be used to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), SpO3, Temperature, and Respiration. For all these vital parameters, the 507EL will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
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    K Number
    K012059
    Device Name
    8100/8500 VITAL SIGNS MONITOR
    Manufacturer
    CRITICARE SYSTEMS, INC.
    Date Cleared
    2001-08-01

    (30 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRITICARE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
    Device Description
    The 8100 / 8500 monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 8100 / 8500 can be configured to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP (IBP), SpO2, Temperature, Respiration, CO2, N2O, O2 and Halogenated Anesthetic Agents. For all these vital parameters, the 8100 / 8500 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
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    K Number
    K001020
    Device Name
    8100 VITAL SIGNS MONITOR
    Manufacturer
    CRITICARE SYSTEMS, INC.
    Date Cleared
    2000-04-28

    (29 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRITICARE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000276
    Device Name
    MPT 24 AND VITAL VIEW 24
    Manufacturer
    CRITICARE SYSTEMS, INC.
    Date Cleared
    2000-03-01

    (30 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRITICARE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961223
    Device Name
    MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS
    Manufacturer
    CRITICARE SYSTEMS, INC.
    Date Cleared
    1996-12-10

    (256 days)

    Product Code
    LOS
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRITICARE SYSTEMS, INC.

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

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