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510(k) Data Aggregation

    K Number
    K161295
    Device Name
    MiniBox +
    Manufacturer
    PULMONE ADVANCED MEDICAL DEVICES, LTD
    Date Cleared
    2016-10-21

    (165 days)

    Product Code
    BZC, BZG
    Regulation Number
    868.1880
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULMONE ADVANCED MEDICAL DEVICES, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by a physician, respiratory therapist, or technician in a hospital or clinic setting
    Device Description
    The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by either a physician, respiratory therapist, or technician. A cleared single-use, disposable viral-bacterial filter separates the patient from the internal components of the device. The MiniBox+ measures all common spirometric measurements as well as relative and absolute lung volumes and diffusing capacity. The MiniBox+ is equipped with a diffusing capacity module which is embedded into the MiniBox+ enclosure and located in the upper end of the device. This feature allows easy measurement of the volumes and concentrations (CO and CH4) of inspired and expired breath, of the test gas mixture and patient sample respectively, making possible the calculation of the diffusion capacity [DLco]. MiniBox + DLco [diffusing capacity factor of the lung for carbon monoxide (CO)] module uses the single breath concept and enables the measurements by setting and controlling the maneuver stages as defined in ATS/ETS DLco guidelines.
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    K Number
    K141793
    Device Name
    PULMONE MINIBOXPFT 2.0
    Manufacturer
    PULMONE ADVANCED MEDICAL DEVICES, LTD.
    Date Cleared
    2015-03-06

    (247 days)

    Product Code
    BZG, BZC
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULMONE ADVANCED MEDICAL DEVICES, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT™ 2.0 is to be used by either a physician, respiratory therapist, or technician.
    Device Description
    The PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT™ 2.0 is to be used by either a physician, respiratory therapist, or technician. A single-use, disposable viral-bacterial filter separates the patient from the internal components of the device. The MiniBoxPFT™ 2.0 measures all common spirometric measurements as well as relative and absolute lung volumes, including the following (the full list is detailed in Section 11 - Device Description): Absolute Lung Volumes: Total lung capacity (TLC) L Thoracic Gas Volume (TGV) L Residual volume (RV) L Relative Lung Volumes: Inspiratory capacity (IC) L Expiratory reserve volume (ERV) L Spirometry: Forced vital capacity (FVC) L Forced inspiratory vital capacity (FIVC) L Slow vital capacity (SVC) L Slow inspiratory vital capacity (IVC) L Forced expiratory volume in 1 second (FEV1) L Forced inspiratory volume in 1 second (FIV1) L Ratio of FEV1 to SVC (FEV1/SVC) % Ratio of FEV1 to FVC (FEV1/FVC) % Forced expiratory volume in 6 seconds (FEV6) L Ratio of FEV1 to FEV6 (FEV1/FEV6) % Peak expiratory flow (PEF) L/s Peak inspiratory flow (PIF) L/s Forced Expiratory Flow at 50% of FVC (FEF50) L/s Maximum Voluntary Ventilation (MVV) L/min
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    K Number
    K133051
    Device Name
    PULMONE MINIBOX PFT TM
    Manufacturer
    PULMONE ADVANCED MEDICAL DEVICES, LTD
    Date Cleared
    2014-05-02

    (217 days)

    Product Code
    BZC, BZG
    Regulation Number
    868.1880
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULMONE ADVANCED MEDICAL DEVICES, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PulmOne MiniBoxPFT is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT is to be used by either a physician, respiratory therapist, or technician.
    Device Description
    The MiniBoxPFT™ is a table-top pulmonary function testing (PFT) device that measures both spirometry and lung volumes. It is developed and manufactured by PulmOne Advanced Medical Devices, Ltd. The MiniBoxPFT™ is composed of two modules: an OEM 510(k) cleared Spirometry module and a Lung Volume Measurement (LVM) module. A single-use, disposable viral-bacterial filter separates the patient from the internal components of the modules.
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