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510(k) Data Aggregation

    K Number
    K221024
    Device Name
    tremoflo C2 Airwave Oscillometry System
    Manufacturer
    Thorasys Thoracic Medical Systems, Inc.
    Date Cleared
    2023-06-20

    (440 days)

    Product Code
    PNV
    Regulation Number
    868.1840
    Why did this record match?
    Product Code :

    PNV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The tremoflo C2 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). The tremoflo C2 Airwave Oscillometry System is intended for use with pediativ and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics, and private physician offices.
    Device Description
    The tremoflo C2 Airwave Oscillometry System (tremoflo C2) is a portable lung function testing device that implements methods known per the Forced Oscillation Technique (FOT), or oscillometry, to assess lung function in humans. The Forced Oscillation Technique (FOT) is a non-invasive test that provides a full report of lung mechanics per the FOT. In general, the FOT usually consists of superimposing given external multi-frequency sinusoidal excitation small pressure waves (1-3 cmH₂O peak) onto the normal breathing of the patient through the device and then deriving the mechanical properties from the patient's mouth pressure and airflow response while breathing. The main outcome reported by FOT is the mechanical impedance of the respiratory system which is the complex ratio between pressure and airflow at the given excitation frequencies. The main tremoflo C2 Unit is a lightweight handheld device. It contains electronics, pressure and flow sensors, and the actuator providing the forced oscillations. The tremoflo software is a complete standalone software package for patient management, testing, result analysis, and presentation. During use the operator holds the handheld device using the ergonomic handle while the patient is seated, wearing a standard nose clip and with hands on cheeks. To perform the test, the patient then breathes quietly through the device into a standard single use Pulmonary Function Testing (PFT) filter connected at the front of the C2 Unit via the PFT filter interface. The tremoflo C2 is not intended to be used as a stand-alone diagnostic device.
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    K Number
    K191876
    Device Name
    PulmoScan
    Manufacturer
    Cognita Labs, LLC
    Date Cleared
    2020-03-18

    (247 days)

    Product Code
    PNV
    Regulation Number
    868.1840
    Why did this record match?
    Product Code :

    PNV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PulmoScan is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). PulmoScan is intended for use with pediatic and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers, similarly trained personnel and patients in hospitals, clinics, private physician offices or home.
    Device Description
    Not Found
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    K Number
    K170185
    Device Name
    tremoFlo C-100 Airwave Oscillometry System
    Manufacturer
    THORASYS Thoracic Medical Systems, Inc.
    Date Cleared
    2017-09-12

    (232 days)

    Product Code
    PNV
    Regulation Number
    868.1840
    Why did this record match?
    Product Code :

    PNV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). tremoFlo C-100 Airwave Oscillometry System is intended for use with pediatric and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics, and private physician offices.
    Device Description
    The tremoFlo C-100 Airwave Oscillometry System (AOS) is a portable lung function testing device that implements methods known per the Forced Oscillation Technique (FOT) to assess lung function in humans. The Forced Oscillation Technique (FOT) is a non-invasive test that requires minimal patient effort and cooperation and provides a full report of lung mechanics per the FOT. In general, the FOT usually consists of superimposing given external multi-frequency sinusoidal excitation small pressure waves (1-3 cmH2O peak to peak) onto the normal breathing of the patient through the device and then deriving the mechanical properties from the patient's mouth pressure and airflow response while breathing. The main outcome reported by FOT is the mechanical impedance of the respiratory system which is the complex ratio between pressure and airflow at the given excitation frequencies. The tremoFlo C-100 Unit is a lightweight handheld device connected to a cradle unit. The handheld unit contains electronics, pressure and flow sensors, and the actuator providing the forced oscillations which is connected to the cradle unit via a custom cable. The tremoFlo software is a complete stand-alone software package for patient management, testing, and result analysis and presentation.
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    K Number
    K152585
    Device Name
    Resmon PRO FULL
    Manufacturer
    MEDICAL GRAPHICS CORP.
    Date Cleared
    2016-06-24

    (288 days)

    Product Code
    PNV, BZC
    Regulation Number
    868.1840
    Why did this record match?
    Product Code :

    PNV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Resmon PRO FULL is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). Resmon PRO FULL is intended for use with pediatric and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics. and private physician offices.
    Device Description
    Resmon PRO FULL is a device for the assessment of the mechanical impedance based on the Forced Oscillation Technique (FOT). FOT is a non-invasive lung function test for measuring the mechanical properties of the respiratory system. It consists in applying very small pressure oscillations (1-3 cmH2O peak-to-peak) of a given frequency/frequencies (usually below 40Hz) at the patient's mouth while she/he is breathing normally. During the test, the device measures pressure at the mouth and airflow to calculate respiratory impedance in real-time. Impedance is the complex ratio between pressure and airflow estimated at the frequency of the stimulating waveform. Common stimulating waveforms range from a simple sinusoid wave to a composite of different frequencies or impulses. The first approach is utilized for tracking swift changes in respiratory impedance. Examples of this include breath changes in lung mechanics or outcome measurements of specific interventions. The latter is used to assess the frequency dependency of impedance (related to the degree of lung heterogeneity) and identify the parameters of mathematical models of the respiratory system. FOT allows for measurement during a patient's normal breathing pattern, with no forced effort required, making it suitable for monitoring non-cooperative patients, such as elderly patients, children or very severely ill patients with limited forced capacity. The test is usually performed with the subject seated, wearing a nose-clip (to prevent airflow leaks from the nose during normal breathing) and with hands on cheeks (to prevent the shunt of the pressure stimulus in the upper airways). The device is not intended to be used as a stand-alone diagnostic device. Resmon PRO FULL consists of a main unit which has been designed to be used stand-alone, without the need of any personal computer, and an adjustable holder with a clamp to fix such unit to a table/desk and to regulate its height and orientation to the patient during an FOT test.
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