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510(k) Data Aggregation

    K Number
    K130208
    Device Name
    BERNOULLI ENTERPRISE SOFTWARE
    Manufacturer
    CARDIOPULMONARY CORP.
    Date Cleared
    2013-12-20

    (326 days)

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

    CARDIOPULMONARY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bernoulli Management System (MS) Software is a software application intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital-type environment. It is used to provide a secondary display of multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO2, blood pressure, cardiac output, temperature and associated derived outputs), lung ventilator, respiratory gas monitor, IV infusion.(including PCA) pump, feeding pump and related ancillary devices, and to provide remote monitoring and alarm surveillance. This application is also intended to provide primary alarm surveillance for devices where no alarm notification capability is enabled or available in low acuity MedSurg, Cardiac, General ward care areas to monitor patients who are currently not monitored. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring procedures. The Bernoulli Management System (MS) Software is to be used under license by or on the order of a physician or licensed healthcare professional in the course of his/her professional practice.
    Device Description
    Not Found
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    K Number
    K091461
    Device Name
    BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE
    Manufacturer
    CARDIOPULMONARY CORP.
    Date Cleared
    2009-08-14

    (88 days)

    Product Code
    MOD, MSX
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOPULMONARY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bernoulli MS software is intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital type environment. It is used to provide a secondary display of ventilator, respiratory monitor, IV infusion (including PCA) pump, feeding pump, and/or multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO2, blood pressure, cardiac output, temperature and associated derived outputs) to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring procedures.
    Device Description
    Not Found
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    K Number
    K061932
    Device Name
    BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE
    Manufacturer
    CARDIOPULMONARY CORP.
    Date Cleared
    2006-09-14

    (69 days)

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

    CARDIOPULMONARY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bernoulli MS software is intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital type environment. It is used to provide a secondary display of ventilator, respiratory monitor, and/or multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO2, blood pressure, cardiac output, temperature and associated derived outputs) to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring. procedures.
    Device Description
    Not Found
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    K Number
    K051283
    Device Name
    MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
    Manufacturer
    CARDIOPULMONARY CORP.
    Date Cleared
    2005-06-23

    (37 days)

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

    CARDIOPULMONARY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bernoulli VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator and respiratory gas monitor data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli VMS is intended to supplement and not replace any part of the current device monitoring procedures.
    Device Description
    Not Found
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    K Number
    K020018
    Device Name
    MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
    Manufacturer
    CARDIOPULMONARY CORP.
    Date Cleared
    2002-02-21

    (49 days)

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

    CARDIOPULMONARY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bernoulli VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator and blood gas monitor data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli VMS is intended to supplement and not replace any part of the current device monitoring procedures.
    Device Description
    Not Found
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    K Number
    K011861
    Device Name
    BERNOULLI VENTILATOR MANAGEMENT SYSTEM
    Manufacturer
    CARDIOPULMONARY CORP.
    Date Cleared
    2001-11-06

    (145 days)

    Product Code
    MOD
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOPULMONARY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bernoulli VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli VMS is intended to supplement and not replace any part of the current device monitoring procedures.
    Device Description
    Bernoulli™ Ventilator Management System
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    K Number
    K990429
    Device Name
    MODIFICATION OF VENTURI VENTILATOR
    Manufacturer
    CARDIOPULMONARY CORP.
    Date Cleared
    1999-02-24

    (13 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOPULMONARY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venturi® ventilator is intended to mechanically control or assist the breathing of adult and pediatric patients. The Venturi® is designed for use in hospital intensive care units (ICU).
    Device Description
    Not Found
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    K Number
    K982174
    Device Name
    VENTURI VENTILATOR
    Manufacturer
    CARDIOPULMONARY CORP.
    Date Cleared
    1998-06-24

    (7 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOPULMONARY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venturi Ventilator is intended to mechanically control and assist the breathing of adult and pediatric patients under the direction of a physician.
    Device Description
    Not Found
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