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Found 8 results
510(k) Data Aggregation
K Number
K130208Device Name
BERNOULLI ENTERPRISE SOFTWARE
Manufacturer
CARDIOPULMONARY CORP.
Date Cleared
2013-12-20
(326 days)
Product Code
MHX, MSX, PFY
Regulation Number
870.1025Why 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
K091461Device 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
868.5895Why 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
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K Number
K061932Device Name
BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE
Manufacturer
CARDIOPULMONARY CORP.
Date Cleared
2006-09-14
(69 days)
Product Code
MSX, MOD
Regulation Number
870.2300Why 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
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K Number
K051283Device Name
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
Manufacturer
CARDIOPULMONARY CORP.
Date Cleared
2005-06-23
(37 days)
Product Code
MSX, MOD
Regulation Number
870.2300Why 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
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K Number
K020018Device Name
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
Manufacturer
CARDIOPULMONARY CORP.
Date Cleared
2002-02-21
(49 days)
Product Code
MSX
Regulation Number
870.2300Why 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
K011861Device Name
BERNOULLI VENTILATOR MANAGEMENT SYSTEM
Manufacturer
CARDIOPULMONARY CORP.
Date Cleared
2001-11-06
(145 days)
Product Code
MOD
Regulation Number
868.5895Why 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
K990429Device Name
MODIFICATION OF VENTURI VENTILATOR
Manufacturer
CARDIOPULMONARY CORP.
Date Cleared
1999-02-24
(13 days)
Product Code
CBK
Regulation Number
868.5895Why 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
K982174Device Name
VENTURI VENTILATOR
Manufacturer
CARDIOPULMONARY CORP.
Date Cleared
1998-06-24
(7 days)
Product Code
CBK
Regulation Number
868.5895Why 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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