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510(k) Data Aggregation

    K Number
    K092217
    Device Name
    MERCURY VCO2
    Manufacturer
    RESPIRONICS NOVAMETRIX, INC.
    Date Cleared
    2009-08-21

    (30 days)

    Product Code
    BZK, CCK
    Regulation Number
    868.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRONICS NOVAMETRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Mercury module with Capnostat 5 is to provide: - spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
    Device Description
    The Mercury module with Capnostat 5 is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography in all of these clinical settings. It is intended to serve the same purposes as the Mercury module with Capnostat 5. The submitted Mercury module with Capnostat 5 is identical to the cleared Mercury Module with Capnostat 5 CO2 sensor. except the nominal upper limit for the specification for the neonatal flow and neonatal CO2/flow sensors used with the Mercury module has been increased from 25 to 30 LPM to align with the specification for maximum inspiratory flow for ventilators cleared for use with neonates. The Mercury module with Capnostat 5 is intended to provide continuous monitoring of respiratory flow and pressure, and CO2 during anesthesia and intensive care and in the emergency department. The flow sensors connect to a patient airway circuit and provide physiological information to the Mercury module. The parameters directly measured and computed by the module (when connected to a Capnostat 5 sensor) include airway flow and pressure, volume, and CO2. The monitor calculates flow by measuring the pressure drop across a known resistance placed in the breathing circuit. CO2 is measured as the absorption of a known intensity of infrared light by CO2 molecules in the airway.
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    K Number
    K042601
    Device Name
    CAPNOSTAT 5
    Manufacturer
    RESPIRONICS NOVAMETRIX, INC.
    Date Cleared
    2004-11-19

    (56 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRONICS NOVAMETRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
    Device Description
    The Capnostat 5 CO2 sensor is designed for continuous, non-invasive monitoring of carbon dioxide .. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters are already legally marketed as accessories to the predicate device. The Capnostat 5 CO2 sensor is an integrated microprocessor based data acquisition system consisting of CO2 measurement, control circuitry and a high speed serial interface. The Capnostat 5 CO2 sensor uses SRAM for data storage and an EEPROM to store system parameters. The firmware resides in a PROM. The operations performed by the Capnostat 5 CO2 sensor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for NoO. O2 and barometric pressure.
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    K Number
    K032971
    Device Name
    TIDAL WAVE SP MODEL 710/715 AND 715
    Manufacturer
    RESPIRONICS NOVAMETRIX, INC.
    Date Cleared
    2004-08-26

    (339 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRONICS NOVAMETRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the TidalWave Sp (Models 710/715) is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care. Separate airway adapters are provided for pediatric/adult and neonatal/pediatric use.
    Device Description
    The Tidal Wave Models 710/715 handheld combined pulse oximeter/capnograph are designed for continuous, non-invasive monitoring of carbon dioxide and functional oxygen saturation. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters and O2 saturation sensors are already legally marketed as accessories to the Model 610 and Model 510 monitors, respectively. The TidalWave Sp monitor is a microprocessor based data acquisition system consisting of CO2 and SpO2 measurement, control circuitry and a high speed serial interface. The monitor uses SRAM for data storage and an EEPROM to store system parameters. The firmware resides in a PROM. The operations performed by the TidalWave Sp monitor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for N2O, O2 and barometric pressure.
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    K Number
    K032949
    Device Name
    SPOT CHECK PULSE OXIMETER,512/513
    Manufacturer
    RESPIRONICS NOVAMETRIX, INC.
    Date Cleared
    2004-08-23

    (336 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRONICS NOVAMETRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 512 Handheld Pulse Oximeter is intended to provide non-invasive spot checking of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport. The Model 513 Handheld Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport. The monitor and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgment of a licensed medical practitioner.
    Device Description
    The Model 512/53 Pulse Oximeters are designed for non-invasive measurement of the functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as successories to the Model 510 monitor. The Model 510 displays digital values of SpO2 and pulse rate. The Model 512/513 consists of a microprocessor based data acquisition system that measures oxygen saturation data. The Model 513 also contains additional circuitry to support battery backed trend data storage and retrieval. Data is stored in a 16Kbyte serial Flash RAM, with time and date retrieved from a separate serial real time clock. The trend data may be transferred serially to a printer or PC via an IRDA compatible chipset.
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    K Number
    K041450
    Device Name
    MODIFICATION TO NICO WITH MARS, MODEL 7300
    Manufacturer
    RESPIRONICS NOVAMETRIX, INC.
    Date Cleared
    2004-06-18

    (17 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRONICS NOVAMETRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the NICO with MARS, Model 7300, monitor is to provide: - cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU). - spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use. - continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). The use of the NICO with MARS, Model 7300, monitor for cardiac output monitoring is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of CO2 level cannot be tolerated.
    Device Description
    The NICO with MARS, Model 7300, is a patient monitor capable of monitoring a patient's cardiac output, spirometry, carbon dioxide, and functional oxygen saturation and pulse rate. In addition, the Model 7300 is capable of communicating with a variety of patient information systems, including the Respironics Esprit ventilator.
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    K Number
    K032755
    Device Name
    MODEL 509M PULSE OXIMETER, MODEL 509M
    Manufacturer
    RESPIRONICS NOVAMETRIX, INC.
    Date Cleared
    2004-05-21

    (259 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRONICS NOVAMETRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 509M Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospital, hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units.
    Device Description
    The Model 509M Pulse Oximeter Module is designed for continuous, non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as accessories to the Model 2001 monitor. The Model 509M displays digital values of SpO₂ and pulse rate and transmits these values as well as the plethysmogram to a Philips Monitoring System via the VueLink Interface. The Model 509M module consists of a dual microprocessor based data acquisition system that measures oxygen saturation data. The firmware for the primary microprocessor is responsible for handling the user interface and communications with external devices via VueLink interface. The firmware for the second microprocessor, a digital signal processor, performs the filtering, pulse rate and saturation calculations of the algorithms which analyze the incoming signals and perform noise reduction on that signal when the presence of noise is detected.
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    K Number
    K030886
    Device Name
    NICO WITH MARS, MODEL 7300
    Manufacturer
    RESPIRONICS NOVAMETRIX, INC.
    Date Cleared
    2003-10-07

    (200 days)

    Product Code
    CCK, BZK, DQA
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRONICS NOVAMETRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the NICO monitor, Model 7300 is to provide: - cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU). - spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use. - continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). The use of the NICO monitor Model 7300 for cardiac output monitoring is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of CO2 level cannot be tolerated.
    Device Description
    The NICO monitor Model 7300 is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography and pulse oximetry in all of these clinical settings. As is its predicate device CO2SMO Plus! with NICO, NICO with MARS is designed to use neonatal, pediatric, and adult combined CO2/flow sensors and single patient use or reusable pulse oximetry sensors. It non-invasively calculates cardiac output using established physiological principles by the application and removal of a rebreathed volume in a patient's breathing circuit and the analysis of that response. The NICO with MARS is intended to provide cardiac output monitoring in mechanically ventilated patients in the operating room and intensive care units. It is intended to serve the same purposes as the CO2SMO Plus! with NICO and MARSPO2, Model 2001. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as accessories to the Model 2001 monitor. As the Model 2001 monitor, the Model 7300 with MARS consists of a dual microprocessor based data acquisition system that measures oxygen saturation data. The firmware for the second microprocessor, a digital signal processor, performs the filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction on that signal when the presence of noise is detected. The Model 7300 can be powered by either an internal power supply operating on AC or by a sealed rechargeable lead-acid gel battery. Audible and visual alarms for high/low saturation and pulse rate are available. There is also a serial port that provides user configurable data output capable of communicating with printers and other devices.
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