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510(k) Data Aggregation
K Number
K142244Device Name
CLEO PATIENT MONITOR
Manufacturer
Date Cleared
2015-02-06
(177 days)
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
INFINIUM MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The purpose and function of the CLEO patient monitor is to monitor basic physiological parameters including
- NIBP (systolic and diastolic)
- SpO2
- ETCO2
The target population is for adults only.
It can be used in all hospital areas and hospital-type facilities. It may be used as bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
Device Description
The CLEO monitor is a comprehensive monitoring system with two or three traces compiling, and processing, analyzing and displaying data from up to three different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.
The CLEO Patient monitor can be powered by an internal battery pack that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
The associated accessories include:
- Sp02 Finger Sensors
- NIBP Monitor
- Blood Pressure Cuff
- ETCO2 Module
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K Number
K132229Device Name
OMNI PATENT MONITORS
Manufacturer
Date Cleared
2014-02-21
(218 days)
Product Code
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
INFINIUM MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The purpose and function of the OMNI patient monitor is to monitor basic physiological parameters including
- ECG waveform derived from 3, 5 or 12 lead measurements .
- Heart Rate .
- NIBP(systolic, diastolic, and mean arterial pressure) .
- . SpO2
- Respiration .
- Temperature up to 2 channels (Dual Temperature) .
- . CO2
- IBP .
- Anesthetic agents .
The target population is for adult, neonate and pediatric patients.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
The purpose and function of the OMNI II patient monitor is to monitor basic physiological parameters including
- ECG waveform derived from 3, 5 or 12 lead measurements .
- Heart Rate .
- NIBP(systolic, diastolic, and mean arterial pressure) .
- SpO2 .
- Respiration .
- Temperature up to 2 channels (Dual Temperature) .
- . CO2
- . Cardiac Output
- IBP .
- . Anesthetic agents
The target population is for adult, neonate and pediatric patients with the exception of:
- · Cardiac Output for which the target population is adult only.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including
- ECG waveform derived from 3, 5 or 12 lead measurements .
- Heart Rate .
- NIBP(systolic, diastolic, and mean arterial pressure) .
- SpO2 .
- Respiration .
- Temperature up to 2 channels (Dual Temperature) .
- CO2 .
- Cardiac Output ●
- . IBP
- Anesthetic agents .
The target population is for adult, neonate and pediatric patients with the exception of:
- · Cardiac Output for which the target population is adult only.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
The purpose and function of the OMNI Express patient monitor is to monitor basic physiological parameters including
- ECG waveform derived from 3 to 5 lead measurements .
- Heart Rate .
- NIBP(systolic, diastolic, and mean arterial pressure) ●
- . SpO2
- . Respiration
- . Temperature - up to 2 channels (Dual Temperature)
- CO2
- . Anesthetic agents
The target population is for adult, neonate and pediatric patients.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
Device Description
The OMNI monitor is a comprehensive monitoring system with four, six or eight traces compiling, and processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.
The OMNI monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
The OMNI II monitor is a comprehensive monitoring system with four, six or eight traces compiling, and processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.
The OMNI II monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
The OMNI III monitor is a comprehensive monitoring system with eight traces compiling, and processing, analyzing and displaying data from up to six different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability, Built-in battery facilitates transportation of patient.
The OMNI III can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
The OMNI EXPRESS monitor is a comprehensive monitoring system with two or three traces compiling, and processing, analyzing and displaying data from up to eight different patient parameters, It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.
The OMNI EXPRESS monitor can be powered by an internal battery pack that provides 2 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
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K Number
K112329Device Name
OMNI PATIENT MONITOR
Manufacturer
Date Cleared
2011-09-08
(27 days)
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
INFINIUM MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The purpose and function of the OMNI Patient monitor is to monitor ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature, for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities.
Device Description
The OMNI patient monitor is a comprehensive monitoring system with three or six traces compiling, processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.
The OMNI patient monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
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K Number
K103737Device Name
OMNI II PATIENT MONITOR
Manufacturer
Date Cleared
2011-06-02
(162 days)
Product Code
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
INFINIUM MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The purpose and function of the OMNI II Patient monitor is to monitor ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature, for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital type facilities such as clinics and emergency room facilities.
Device Description
The OMNI II monitor is a comprehensive monitoring system with four, six or eight traces compiling, processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient. The OMNI II monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
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K Number
K103268Device Name
OMNI EXPRESS
Manufacturer
Date Cleared
2010-11-23
(19 days)
Product Code
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
INFINIUM MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The purpose and function of the Omni Express patient monitor is to monitor basic physiological parameters including, ECG, heart rate. NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals anf hospital-type facilities such as clinics and emergency room facilities.
Device Description
The OMNI Express patient monitor is a comprehensive monitoring system with two or three traces compiling, processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.
The OMNI Express monitor can be powered by an internal battery pack that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
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K Number
K101052Device Name
OMNI III PATIENT MONITOR
Manufacturer
Date Cleared
2010-08-11
(118 days)
Product Code
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
INFINIUM MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including, ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities.
Device Description
The OMNI III monitor is a comprehensive monitoring system with eight traces compiling, processing, analyzing and displaying data from up to six different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.
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