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510(k) Data Aggregation

    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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